U.S. Food & Drug Administration 10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 3 . 0 3 Silver Spring, MD 20993 www.fda.gov

Visionare LLC December, 28, 2018 ℅ Kevin Thomas, Ph.D Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130 Re: K180204

Trade/Device Name: CranioMaxillofacial Fixation (CMF) System - CMF Visionare Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: November 26, 2018 Received: November 27, 2018

Dear Kevin Thomas: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

K180204 - Kevin Thomas, Ph.D Page

2

801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Mary S. Runner -S3

Digitally signed by Mary S. Runner -S3 Date: 2018.12.28 08:25:15 -05'00'

FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.

510(k) Number (if known)

Device Name

C

Indications for Use (Describe)CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov

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510(k) Summary K180204 Page 1 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

510(k) Summary

K180204

CranioMaxillofacial Fixation (CMF) System – CMF Visionare

Visionare LLC November 26, 2018

ADMINISTRATIVE INFORMATION

Manufacturer Name Visionare LLC 12251 Towne Lake Drive Fort Meyers, FL 33913 Telephone +1 239-244-2973

Official Contact Mariana de Oliveira Quinzani Regulatory Affairs Representative/Consultant Kevin A. Thomas, PhD Floyd G. Larson, MS, MBA PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: +1 858-792-1235 Fax: +1 858-792-1236 Email: kthomas@paxmed.com flarson@paxmed.com DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name CranioMaxillofacial Fixation (CMF) System - CMF Visionare Common Names Bone plate; Fixation screws

Primary Classification Name Bone Plate Primary Classification Regulation 21 CFR 872.4760, Class II Primary Product Code JEY

Secondary Classification Name Intraosseous fixation screw or wire Secondary Classification Regulation 21 CFR 872.4880, Class II Secondary Product Code DZL

Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION

Primary Predicate K102641, Mini and Micro Fragments Reconstruction System – NEOFACE, NEOORTHO Produtos Ortopédicos S/A Reference Devices K021642, Synthes Craniofacial Plates, Synthes (USA) K050934, MODUS® Titanium Osteosynthesis System, Medartis, Inc. K033065, 2.0 mm Craniofacial Locking Plates, Synthes (USA)

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510(k) Summary K180204 Page 2 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

K972322, Lorenz 1.5mm Neuro Pack/Lorenz 2.0 FT Plates (sterile version), Walter Lorenz Surgical, Inc. K080694, OsteoMed Modular Locking Fixation System, OsteoMed LP K091144, Synthes MatrixMANDIBLE Preformed Reconstruction Plates, Synthes USA K992682, MODUS 2.5 Mandibular Reconstruction Set, Medartis K063052, Mandibular Fracture/Reconstruction Devices and Pre-Bent Plates, Walter Lorenz Surgical, Incorporated K980199, Synthes® (USA) 1.5mm/2.0mm Orthognathic Maxillary Plates and Screws, Synthes® (USA) K031708, Osteomed Maxillary/LeFort III Distraction System, OsteoMed L.P. K944565, KLS-Martin Micro Osteosynthesis System (1.5 mm), KLS-Martin L.P. K052061, MODUS IMF SCREWS 2.0, Medartis, Inc. INDICATIONS FOR USE STATEMENT

CranioMaxillofacial Fixation (CMF) System – CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin. SUBJECT DEVICE DESCRIPTION

The subject device is a fixation system consisting of plates and screws in a variety of shapes and sizes. All plates are made of commercially pure titanium conforming to ASTM F67, and all screws are made of Ti-6Al-4V alloy conforming to ASTM F136. The subject device includes the following groups: 1.5 System Plate, 2.0 System Plates, 2.4 System Plates, Orthognathic Plates, Blocking Screws (for intermaxillary fixation, 2.0 mm diameter), and screws for use with the various plates ranging in diameter from 1.5 mm to 2.7 mm. The dimensions of the plates are provided in the comparison tables in this summary. PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937; biocompatibility testing according to ISO 10993-5 and ISO 10993-12; dimensional analysis; engineering analysis; mechanical testing to ASTM F382 (single cycle bending and bending fatigue) and ASTM F543 (torsional properties, driving torque, axial pullout, self-tapping performance). No clinical data were included in this submission. EQUIVALENCE TO MARKETED DEVICE

Visionare LLC submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA’s regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed devices cited above. The subject device is substantially equivalent to the primary predicate device K102641 in intended use, Indications for Use, designs, materials, and function. The Indications for Use statement for the subject device is identical to that of the primary predicate K102641 except for the names of the devices. A comparison of the Indications for Use Statements and technological characteristics of the subject device, the primary predicate device, and the reference devices is provided in the following tables. Differences in the design features between the subject device and the primary predicate device K102641 are addressed by comparison to the reference devices as listed below.

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510(k) Summary K180204 Page 3 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

Table 1 – Substantial Equivalence 1.5 System Plates

Subject Device Primary Predicate Device Reference Device Reference Device

Comparisons K180204 Mini and Micro Fragments Reconstruction System – CMF Visionare Visionare LLC

K102641 Mini and Micro Fragments Reconstruction System – NEOFACE NEOORTHO Produtos Ortopédicos S/A

K021642 Synthes Craniofacial Plates Synthes (USA)

K050934 MODUS® Titanium Osteosynthesis System Medartis, Inc.

Indications for Use Statement

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Mini and Micro Fragments Reconstruction System - NEOFACE is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

The Synthes Craniofacial Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

The MODUS® Titanium Osteosynthesis System is intended for osteotomies and fractures involving any part of the craniofacial skeleton and requiring positional and functional stability. Indications include fixation in the nasoethmoidal, intraorbital, and frontal sinus areas; fixation of comminuted fractures of maxillo-facial and craniofacial areas; tumor surgery for defect bridging; reconstruction of bony structures by means of mesh materials; coverings for burr holes in the skull; trauma of nasal bones; surgical correction of dentofacial deformations; and reconstruction after tumor surgery.

Plate Designs for Comparison

1.5 Straight Plates 1.5 Rectangular Plates 1.5 T Plates 1.5 Y Plates 1.5 Double Y Plates 1.5 L Plates 1.5 L 110° Plates 1.5 H Plates 1.5 X Plates 1.5 Z Plates 1.5 Orbital Plates 1.5 Orbital Floor Plates

Straight Plates Rectangular Plates T Plates Y Plates Double Y Plates L Plates L 110° Plates H Plates X Plates Z Plates Orbital Plates

Rectangular Plates Y Plates Double Y Plates L Plates H Plates Z Plates Orbital Plates

T Plates Y Plates L 110° Plates

Comparison of Designs

Thickness (mm)

Overall Sizes (mm)

Thickness (mm)

Overall Sizes (mm)

Thickness (mm)

Overall Sizes (mm)

Thickness (mm)

Overall Sizes (mm)

1.5 Straight Plates 1.5 Straight Plates 0.7 8.8 - 79.2 Straight Plates 0.7 10.3 - 79.2

1.5 Rectangular Plates 1.5 Rectangular Plates 0.7 Rectangular Plates 0.7 Rectangular Plates (Box Plates)

0.7

2x2 hole (7.2 - 10.3) x 10.3 2x2 hole 11.7 x 11.7 2x2 (holes) (5.0 - 10.0) x 10 2x3 hole 17.4 x 10.3 2x3 hole 17.4 x 10.3 2x4 hole 24.4 x 10.3 2x4 hole 24.5 x 10.3 1.5 T Plates 1.5 T Plates 0.7 T Plates 0.7 T Plates 0.6 3x2 hole (11.2 - 15.7) x 11.2 None 3x2 hole 12.0 x 12.0 3x3 hole (15.2 - 19.7) x 11.2 3x3 hole 15.2 x 11.2 3x3 hole 17.0 x 12.0 3x4 hole (19.2 - 23.7) x 11.2 7x7 hole 31.2 x 27.2 3x4 hole 21.0 x 12.0 1.5 Y Plates 1.5 Y Plates 0.7 Y Plates 0.7 Y Plates 0.6 Y Plates 3x3 hole (18.0 - 22.5) x 8.9 3x2 hole (15.6 - 18.5) x 8.9 3x3 hole 22.0 x 11.0 3x2 hole 0.6 (16.0 - 20.0) x 10.0 5x4 hole (24.9 - 29.4) x 14.5 None 5x4 hole 0.7 (25.0 - 30.0) x 16.0 1.5 Double Y Plates 1.5 Double Y Plates 0.7 Double Y Plates 0.7 Double Y Plates 3x3 hole (13.1 - 17.4) x 8.9 3x3 hole (14.5-17.4) x 8.9 5x5 hole (18.5 - 23.0) x 14.5 None 0.6 (18.0 - 21.0) x 11.4 1.5 L Plates 1.5 L Plates 0.7 L Plates 0.7 2x2 hole (11.4 - 15.7) x 7.2 2x2 hole (12.8-15.7) x 7.2 1.5 L 110° Plates 1.5 L 110° Plates 0.7 L 110° Plates 0.7 L Oblique Plates 0.6 L 110° Plates 0.6 3x3 hole (18.1 - 22.4) x 11.2 3x3 hole (19.7-21.0) x 11.2 2x3 hole 22.0 x 9.0 2x2 hole (18.0 - 21.0) x 8.0 3x4 hole (22.1 - 26.4) x 11.2 None 3x4 hole 27.0 x 13.0 1.5 H Plates 1.5 H Plates 0.7 16.7 x 15.2 H Plates 0.7 20.4 x 19.2 H Plates 0.5 19.0 x 13.0 1.5 X Plates 1.5 X Plates 0.7 11.2 x 11.2 X Plates 0.7 11.2 x 11.2 1.5 Z Plates 1.5 Z Plates 0.7 (10.5 - 13.4) x 11.2 Z Plates 0.7 (11.7-14.6) x 11.1 Z Plates 0.6 (10.9-14.7) x 15

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510(k) Summary K180204 Page 4 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

Table 1 – Substantial Equivalence 1.5 System Plates

Subject Device Primary Predicate Device Reference Device Reference Device

Comparisons K180204 Mini and Micro Fragments Reconstruction System – CMF Visionare Visionare LLC

K102641 Mini and Micro Fragments Reconstruction System – NEOFACE NEOORTHO Produtos Ortopédicos S/A

K021642 Synthes Craniofacial Plates Synthes (USA)

K050934 MODUS® Titanium Osteosynthesis System Medartis, Inc.

1.5 Orbital Plates 1.5 Orbital Plates 0.7 Orbital Plates 0.7 Orbital Plates 0.6 6 hole 23.0 - 27.3 6 hole 23.0 6 hole 34.0 8 hole 30.6 - 34.8 8 hole 30.6 8 hole 41.0 10 hole 37.9 - 41.9 10 hole 37.9 10 hole 49.0 1.5 Orbital Floor Plates 1.5 Orbital Floor Plates 0.3 Orbital Floor Plates 0.3 Orbital Floor Plates Orbital Floor Plate, T 0.3 mm 59.7 x 36.8 x 0.30 mm Orbital Floor Plate (0.2 - 0.4) 62.2 x 38.5

Regular Anatomical Orbital Floor Plate, T 0.3 mm

29.0 x 17.0 x 0.30 mm Small 0.3 21.0 x 13.3

Medium Anatomical Orbital Floor Plate, T 0.3 mm

47.7 x 39.6 x 0.30 mm Medium 0.3 30.6 x 26.6

Wide Medium Anatomical Orbital Floor Plate, T 0.3 mm

53.1 x 39.6 x 0.30 mm Large 0.3 41.3 x 34.6

Large Anatomical Orbital Floor Plate, T 0.3 mm

61.1 x 53.5 x 0.30 mm

Universal Orbital Floor Plate, T 0.3 mm

58.1 x 52.1 x 0.30 mm Orbital Floor Plate 56.7 x 49.9

Plate Material CP Titanium CP Titanium CP Titanium CP Titanium

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510(k) Summary K180204 Page 5 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

Table 2 – Substantial Equivalence 2.0 System Plates

Subject Device Primary Predicate Device Reference Device Reference Device Reference Device Reference Device Reference Device

Comparison

K180204 Mini and Micro Fragments Reconstruction System – CMF Visionare Visionare LLC

K102641 Mini and Micro Fragments Reconstruction System – NEOFACE NEOORTHO Produtos Ortopédicos S/A

K021642 Synthes Craniofacial Plates Synthes (USA)

K033065 2.0 mm Craniofacial Locking Plates Synthes (USA)

K972322 Lorenz 1.5mm Neuro Pack/Lorenz 2.0 FT Plates (sterile version) Walter Lorenz Surgical, Inc.

K050934 MODUS® Titanium Osteosynthesis System Medartis, Inc.

K080694 OsteoMed Modular Locking Fixation System OsteoMed LP

Indications for Use Statement

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Mini and Micro Fragments Reconstruction System - NEOFACE is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

The Synthes Craniofacial Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Synthes 2.0 mm Craniofacial Locking Plates are indicated for selective trauma of the midface and craniofacial skeleton; craniofacial surgery, reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Rigid fixation of cranio, facial and neurological bone.

The MODUS® Titanium Osteosynthesis System is intended for osteotomies and fractures involving any part of the craniofacial skeleton and requiring positional and functional stability. Indications include fixation in the nasoethmoidal, intraorbital, and frontal sinus areas; fixation of comminuted fractures of maxillo-facial and craniofacial areas; tumor surgery for defect bridging; reconstruction of bony structures by means of mesh materials; coverings for burr holes in the skull; trauma of nasal bones; surgical correction of dentofacial deformations; and reconstruction after tumor surgery.

The OsteoMed Modular Locking Fixation System is intended for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The OsteoMed Modular Locking Fixation System implants and drills are intended for single use only.

Plate Designs for Comparison

2.0 Straight Plates 2.0 Rectangular Plates 2.0 T Plates 2.0 Y Plates 2.0 Double Y Plates 2.0 L Plates 2.0 L 110° Plates 2.0 H Plates 2.0 I Plates 2.0 X Plates 2.0 Z Plates 2.0 Orbital Plates 2.0 Straight Locking Plates 2.0 Rectangular Locking Plates

Straight Plates T Plates Y Plates Double Y Plates L Plates Z Plates Orbital Plates Straight Locking Plates

Straight Plates Rectangular Plates Y Plates Double Y Plates L 110° Plates H Plates X Plates

Straight Locking Plates Rectangular Locking Plates

Z Plates Orbital Plates

Rectangular Plates T Plates L 100° Plates I Plates Orbital Plates Straight Locking Plates

Y Plates

Comparison of Designs Thickness (mm)/ Features

Overall Sizes (mm)

Thickness (mm)/ Features

Overall Sizes (mm)

Thickness (mm)/ Features

Overall Sizes (mm)

Thickness (mm)/ Features

Overall Sizes (mm)

Thickness (mm)/ Features

Overall Sizes (mm)

Thickness (mm)/ Features

Overall Sizes (mm)

Thickness (mm)/ Features

Overall Sizes (mm)

2.0 Straight Plates 1.0 mm 14.0 – 126.1 1.0 14.0 – 100.5 0.9 mm 24.0 – 193.0 2.0 Rectangular Plates 1.0 mm 0.9 mm 1.0 mm 2x2 hole (10.9 – 17) x 17 2x2 hole (5x10) – (15x15) 2x2 holes (10-13) x 13 2x3 hole 29.5 x 17 2x3 hole 25x15 2x3 hole 22 x 13 2x4 hole 31 x 13 2.0 T Plates 1.0 mm 1.0 mm 1.0 mm 3x2 hole (17.3-26.4) x 17.3 3x2 hole (23.4-26.4) x 17.3 3x2 hole (17-20) x 17 2.0 Y Plates 1.0 mm 1.0 mm 0.9 mm 1.0 mm 3x3 hole (28.2-37.3) x 13.5 3x2 hole (21.8-27.9)x13.6 2x3 hole 24.0 x 12.0 6x6 hole 36.0 x 21.0 5x4 hole 39.2 x 22.6 4x4 hole 32.0 x 19.0

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510(k) Summary K180204 Page 6 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

Table 2 – Substantial Equivalence 2.0 System Plates

Subject Device Primary Predicate Device Reference Device Reference Device Reference Device Reference Device Reference Device

Comparison

K180204 Mini and Micro Fragments Reconstruction System – CMF Visionare Visionare LLC

K102641 Mini and Micro Fragments Reconstruction System – NEOFACE NEOORTHO Produtos Ortopédicos S/A

K021642 Synthes Craniofacial Plates Synthes (USA)

K033065 2.0 mm Craniofacial Locking Plates Synthes (USA)

K972322 Lorenz 1.5mm Neuro Pack/Lorenz 2.0 FT Plates (sterile version) Walter Lorenz Surgical, Inc.

K050934 MODUS® Titanium Osteosynthesis System Medartis, Inc.

K080694 OsteoMed Modular Locking Fixation System OsteoMed LP

2.0 Double Y Plates 1.0 mm 1.0 mm 0.9 mm 3x3 hole (20.0-29.1) x 13.5 3x3 hole (20.0-26.1)x13.6 2x3 24.0 x 12.0 5x5 hole (29.0-32.1) x 22.6 4x4 32.0 x 19.0 2.0 L Plates 1.0 mm 1.0 mm 2x2 hole (17.3-26.4) x 10.9 2x2 hole (17.3-26.4) x 10.9

2.0 L 110° Plates 1.0 mm

0.9 mm 2.0 Oblique L-Plates

1.0 mm 2.0 L 110° Plates

3x3 hole (23.7-32.8) x 17.3 2x3 hole 25.0 x 10.0 3x3 hole 34.0 x 17.0

3x4 hole (30.1-39.2) x 11.2 3x4 hole

(25.0-31.0) x (10.0-15.0)

4x6 hole 42.9 x 23.7 4x6 hole 41.0 x 20.0 2.0 H Plates 1.0 mm 0.9 mm 8 hole 26.1 x 23.7 23.0 x 22.0 9 hole 26.1 x 23.7 2.0 I Plates 1.0 mm 1.0 mm (17.0-23.0) x 11.0 4 hole (14.0-20.0) x 10.9 2.0 X Plates 1.0 mm 17.3 x 17.3 0.9 mm 18.0 x 18.0 2.0 Z Plates 1.0 mm (14.0-20.0) x 20.2 1.0 mm (13.1-19.2) x 17.1 0.6 mm (19.1 - 22.9) x 20.4 2.0 Orbital Plates 1.0 mm Lengths 1.0 mm Lengths 1.0 mm Length 1.0 mm Length 6 hole 35.6 – 43.8 6 hole 42.0 mm 6 hole 35.0 mm 8 hole 46.9 – 54.2 8 hole 40.7 8 hole 54.7 mm 8 hole 47.0 mm 2.0 Straight Locking Plates 1.0 mm Lengths 1.0 mm Lengths 1.0 mm Lengths

11.9 – 85.0 15.5 – 53.4 24.5 – 100.0 1.5 mm Lengths 1.3 mm Lengths 1.25 mm Lengths 1.5 mm Lengths 30.5 - 102.0 30.5 – 54.0 40.4 – 70.5 34.0 – 142.0 2.0 Rectangular Locking Plates 1.0 mm 1.0 mm

2x2 hole 10.9 x 10.9 2x2 hole 12.3 x 12.3 2x2 / 2x2 hole 35.2 x 10.9 2x2 / 2x2 hole 33.0 x 12.3 Plate Material CP Titanium CP Titanium CP Titanium CP Titanium CP Titanium CP Titanium CP Titanium; Ti-6Al-4V alloy

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510(k) Summary K180204 Page 7 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

Table 3 – Substantial Equivalence 2.4 System Plates

Subject Device Primary Predicate Device Reference Device Reference Device Reference Device

Comparison

K180204 Mini and Micro Fragments Reconstruction System – CMF Visionare Visionare LLC

K102641 Mini and Micro Fragments Reconstruction System – NEOFACE NEOORTHO Produtos Ortopédicos S/A

K091144 Synthes MatrixMANDIBLE Preformed Reconstruction Plates Synthes USA

K992682 MODUS 2.5 Mandibular Reconstruction Set Medartis

K063052 Mandibular Fracture/Reconstruction Devices and Pre-Bent Plates Walter Lorenz Surgical, Incorporated

Indication for Use Statement

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Mini and Micro Fragments Reconstruction System - NEOFACE is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.

The indications for use of the MODUS® 2.5 Reconstruction Set include use in reconstruction surgery, including bone grafting and bridging defects in the mandible after tumor resection or severe infection. It is also indicated for use in mandibular trauma, e.g. unstable, comminuted mandibular fractures and bone loss.

Intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

Plate Designs for Comparison

2.4 Straight Reconstruction Plates 2.4 Anatomic Reconstruction Plates 2.4 Angled Reconstruction Plates 2.4 Double Angled Reconstruction Plates

Straight Reconstruction Plates Anatomic Reconstruction Plates Double Angled Reconstruction Plates

Straight Reconstruction Plates Anatomic Reconstruction Plates Angled Reconstruction Plates Double Angled Reconstruction Plates

Anatomic Reconstruction Plates Angled Reconstruction Plates Double Angled Reconstruction Plates

Straight Reconstruction Plates Anatomic Reconstruction Plates

Comparison of Designs Thickness (mm)/ Features

Lengths or Overall Sizes (mm)

Thickness (mm)/ Features

Lengths or Overall Sizes (mm)

Thickness (mm)/ Features

Lengths or Overall Sizes (mm)

Thickness (mm)/ Features

Lengths or Overall Sizes (mm)

Thickness (mm)/ Features

Lengths or Overall Sizes (mm)

2.4 Straight Reconstruction Plates

2.0 mm 2.0 mm 82.8 – 139.2 1.8 mm 39.0 – 141.8 4-12 hole 38.0 – 118.0 2.54 mm 2.54 mm 58.0 – 78.0 2.5 mm 81.9 – 192.0 6-12 hole 58 – 118 2.4 Anatomic Reconstruction Plates

2.0 mm 1.6 mm 72.0 – 139.0 1.8 mm 55.1 6-14 hole 57.9 – 135.9 2.54 mm 57.9 – 164.9 2.54 mm 58.0 – 78.0 2.5 mm 81.9 – 192.0 6-17 hole (straight plates) (straight plates) 2.4 Angled Reconstruction Plates

2.0 mm 2.0 mm 1.6 mm 2x2 hole 23.4 x 23.4 2x2 19.0 x 19.0 3x3 hole 33.4 x 33.4 3x3 28.0 x 28.0 4x4 hole 43.4 x 43.4 4x4 37.0 x 37.0 4x17 hole 168.2 x 42.5 6x21 hole 168.0 x 46.1 5x17 hole 167.7 x 53.1 6x21 hole 168.0 x 46.1 2.54 mm 2.5 mm 3x3 hole 33.4 x 33.4 3x3 hole 32.5 x 32.5 4x4 hole 43.4 x 43.4 4x4 hole 42.1 x 42.1 4x17 hole 168.2 x 42.5 6x21 170.0 x 50.0 5x17 hole 167.7 x 53.1 6x21 170.0 x 50.0

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510(k) Summary K180204 Page 8 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

Table 3 – Substantial Equivalence 2.4 System Plates

Subject Device Primary Predicate Device Reference Device Reference Device Reference Device

Comparison

K180204 Mini and Micro Fragments Reconstruction System – CMF Visionare Visionare LLC

K102641 Mini and Micro Fragments Reconstruction System – NEOFACE NEOORTHO Produtos Ortopédicos S/A

K091144 Synthes MatrixMANDIBLE Preformed Reconstruction Plates Synthes USA

K992682 MODUS 2.5 Mandibular Reconstruction Set Medartis

K063052 Mandibular Fracture/Reconstruction Devices and Pre-Bent Plates Walter Lorenz Surgical, Incorporated

2.4 Double Angled Reconstruction Plates

2.0 mm 2.0 mm 4x17x4 hole 42.9 x 174.5 x 42.9 5x22x5 40.9 x 181.5 x 40.9 4x20x4 hole 43.2 x 201.2 x 43.2 6x24x6 48.7 x 197.6 x 48.7 2.54 mm 2.54 mm 2.5 mm 4x17x4 hole 42.9 x 174.5 x 42.9 4x17x4 42.5 x 172.4 x 42.5

4x20x4 hole 43.2 x 201.2 x 43.2 5x22x5 (28.7-41.1) x (177.1-250.1) x (28.7-41.1)

5x17x5 hole 53.0 x 174.5 x 53.0 4x17x4 49.0 x 176.0 x 49.0 5x20x5 hole 53.2 x 201.2 x 53.2 5x19x5 60.0 x 198.0 x 60.0 Plate Material CP Titanium CP Titanium CP Titanium CP Titanium CP Titanium

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510(k) Summary K180204 Page 9 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

Table 4 – Substantial Equivalence Orthognathic Plates

Subject Device Primary Predicate Device Reference Device Reference Device Reference Device Reference Device

Comparison

K180204 Mini and Micro Fragments Reconstruction System – CMF Visionare Visionare LLC

K102641 Mini and Micro Fragments Reconstruction System – NEOFACE NEOORTHO Produtos Ortopédicos S/A

K980199 Synthes® (USA) 1.5mm/2.0mm Orthognathic Maxillary Plates and Screws Synthes® (USA)

K031708 Osteomed Maxillary/LeFort III Distraction System OsteoMed L.P.

K944565 KLS-Martin Micro Osteosynthesis System (1.5 mm) KLS-Martin L.P.

K050934 MODUS® Titanium Osteosynthesis System Medartis, Inc.

Indication for Use Statement

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Mini and Micro Fragments Reconstruction System - NEOFACE is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, they are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Intended for use in the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and micrognathia. The OsteoMed Maxillary / LeFort III Distraction device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones. The OsteoMed Maxillary / LeFort Ill Distraction System is intended for single patient use only.

Not available on FDA 510(k) database webpage The MODUS® Titanium Osteosynthesis System is intended for osteotomies and fractures involving any part of the craniofacial skeleton and requiring positional and functional stability. Indications include fixation in the nasoethmoidal, intraorbital, and frontal sinus areas; fixation of comminuted fractures of maxillo-facial and craniofacial areas; tumor surgery for defect bridging; reconstruction of bony structures by means of mesh materials; coverings for burr holes in the skull; trauma of nasal bones; surgical correction of dentofacial deformations; and reconstruction after tumor surgery.

Plate Designs for Comparison

Orthognathic L Plates Orthognathic Y Plates Orthognathic Canine Pillar Plates Orthognathic Zygomatic Pillar Plates Orthognathic Le Fort Plates Orthognathic Chin Plates Orthognathic Paulus Plates Orthognathic Straight Sagittal Plates Orthognathic Straight Adjustable Sagittal Plates Orthognathic Y Adjustable Sagittal Plates Orthognathic Locking Straight Sagittal Plates Orthognathic Locking Straight Adjustable Sagittal Plates Orthognathic Locking Y Adjustable Sagittal Plates

Orthognathic L Plates Orthognathic Y Plates Orthognathic Le Fort Plates Orthognathic Chin Plates Orthognathic Paulus Plates Orthognathic Straight Sagittal Plates Orthognathic Locking Straight Sagittal Plates

Orthognathic L Plates Orthognathic Y Plates Orthognathic Zygomatic Pillar Plates Orthognathic Y Adjustable Sagittal Plates Orthognathic Locking Y Adjustable Sagittal Plates

Orthognathic Y Plates Orthognathic Le Fort Plates

Orthognathic Le Fort Plates Orthognathic L Plates Orthognathic Y Plates Orthognathic Canine Pillar Plates Orthognathic Zygomatic Pillar Plates Orthognathic Le Fort Plates Orthognathic Chin Plates Orthognathic Paulus Plates Orthognathic Straight Sagittal Plates Orthognathic Straight Adjustable Sagittal Plates Orthognathic Y Adjustable Sagittal Plates Orthognathic Locking Straight Sagittal Plates Orthognathic Locking Straight Adjustable Sagittal Plates Orthognathic Locking Y Adjustable Sagittal Plates

Comparison of Designs Thickness (mm)/ Features

Lengths or Overall Sizes (mm)

Thickness (mm)/ Features

Lengths or Overall Sizes (mm)

Thickness (mm)/ Features

Lengths or Overall Sizes (mm)

Thickness (mm)/ Features

Lengths or Overall Sizes (mm)

Thickness (mm)/ Features

Lengths or Overall Sizes (mm)

Thickness (mm)/ Features

Lengths or Overall Sizes (mm)

Orthognathic L Plates 0.7 mm (12.8 - 15.7) x 7.2 0.7 (12.8 - 15.7) x 7.2 1.0 mm (20.4 - 26.4) x 10.9 1.0 (17.3 - 26.4) x 10.9 Orthognathic L Plates with offset 0.7 mm 13.9 x 7.2 (2 -11 offset) 0.7 (12.8-15.7) x 7.2 1.0 mm 19.1 x 10.9 (2 -11 offset) 1.0 (17.3 - 26.4) x 10.9 Orthognathic 110° L Plates 0.7 mm 0.7 mm 3x3 hole (19.5 - 22.4) x 11.2 3x3 hole (19.7 - 21.0) x 11.2 1.0 mm 0.5 - 0.7 1.0 mm 3x3 hole (26.8 - 32.8) x 17.3 4x3 hole (23.0 - 27.0) x 17.0 3x3 hole 34.0 x 17.0 Orthognathic Y Plates 0.7 mm 0.7 mm 0.7 mm

3x3 hole (18.2 - 22.5) x 8.9 3x2 hole (15.6 - 18.5) x 8.9 3x3 hole (16.0 - 30.0) x (10.0 - 16.0)

5x4 hole (25.1 - 29.4) x 14.5 5x4 holes (25.0 - 30.0) x 16.0 1.0 mm 1.0 mm 1.0 mm 1.0 mm 3x3 hole (28.2 - 37.3) x 13.6 3x2 hole (21.8 - 27.9) x 13.6 4x4 hole 32.0 x 19.0 6x6 hole 36.0 x 21.0 K080694 (See Table for 2.0 System) 1.0 mm 1.0 mm 5x4 hole 39.2 x 22.6 6x6 hole 36.0 x 21.0

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510(k) Summary K180204 Page 10 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

Table 4 – Substantial Equivalence Orthognathic Plates

Subject Device Primary Predicate Device Reference Device Reference Device Reference Device Reference Device

Comparison

K180204 Mini and Micro Fragments Reconstruction System – CMF Visionare Visionare LLC

K102641 Mini and Micro Fragments Reconstruction System – NEOFACE NEOORTHO Produtos Ortopédicos S/A

K980199 Synthes® (USA) 1.5mm/2.0mm Orthognathic Maxillary Plates and Screws Synthes® (USA)

K031708 Osteomed Maxillary/LeFort III Distraction System OsteoMed L.P.

K944565 KLS-Martin Micro Osteosynthesis System (1.5 mm) KLS-Martin L.P.

K050934 MODUS® Titanium Osteosynthesis System Medartis, Inc.

Orthognathic Canine Pillar Plates 0.7 mm 0.7 mm 3x3 hole (16.7 - 19.6) x 11.2 2x2 (17.0 -19.0) x 8.0 3x2 26.0 x 8.0 3x3 (26.0 - 31.0) x 13.0 1.0 mm 3x3 hole (26.5 - 32.2) x 17.3 3x3 (26.0 - 31.0) x 13.0 Orthognathic Zygomatic Pillar Plates 0.7 mm (15.8 - 18.3) x 11.2 0.7 mm (22.0 - 31.0) x 12.0 0.7 mm 2x2 hole 17.0 x 8.0

3x3 hole (25.0 - 31.0) x (15.0 - 16.0)

1.0 mm (23.9 - 28.3) x 17.3 0.8 mm (23.8 - 34.3) x 13.5 0.7 mm 3x3 hole

(25.0 - 31.0) x (15.0 - 16.0)

Orthognathic Le Fort Plates 0.7 mm 29.0 x 23.2 (0 -10 offset)

0.7 mm 33.8 x 25.2 (2 -11 offset)

0.7 mm 25.5 x 23.8 (2-12 offset)

1.0 mm 29.5 x 21.5 (0-11 offset)

0.7 mm (23.0 - 31.0) x 25.0 (0 - 11 offset)

Orthognathic Chin Plates 0.7 mm 15.0 x 11.9 (0 -16 offset)

1.0 15.0 x 11.9 (2.5 -16 offset)

0.6 mm (19.0 - 24.0) x (16.0 x 21.0) (0 - 11 offset)

Orthognathic Paulus Plates 0.7 mm 15.0 x 13.9 (0 -16 offset)

1.0 15.0 x 14.0 (2 -16 offset)

0.6 mm (19.0 - 24.0) x (16.0 x 21.0) (0 - 11 offset)

Orthognathic Straight Sagittal Plates 1.0 mm 21.6 - 36.6 1.0 mm 25.2 - 34.2 1.0 mm 27.0 - 49.0 Orthognathic Straight Adjustable Sagittal Plates

1.0 mm 26.6 - 41.6 0.7 mm 33.0 – 40.0 0.7 / 0.8 mm 27.0 - 47.0

Orthognathic Y Adjustable Sagittal Plates

1.0 mm 26.2 – 41.7 1.0 mm 23.5 – 30.0 0.7 / 0.8 mm (Straight)

27.0 - 47.0

Orthognathic Locking Straight Sagittal Plates

1.0 mm 22.3 - 37.3 1.0 25.2 - 34.2 1.0 mm 27.0 - 49.0

Orthognathic Locking Straight Adjustable Sagittal Plates

1.0 mm 26.6 - 41.6 0.7 / 0.8 mm 27.0 - 47.0

Orthognathic Locking Y Adjustable Sagittal Plates

1.0 mm 28.1 - 43.1 1.0 mm 23.5 – 30.0 0.7 / 0.8 mm (Straight)

27.0 - 47.0

Plate Material CP Titanium CP Titanium CP Titanium CP Titanium CP Titanium CP Titanium

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510(k) Summary K180204 Page 11 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

Table 5 – Substantial Equivalence Blocking Screws

Subject Device Primary Predicate Device Reference Device

Comparison K180204 Mini and Micro Fragments Reconstruction System – CMF Visionare Visionare LLC

K102641 Mini and Micro Fragments Reconstruction System – NEOFACE NEOORTHO Produtos Ortopédicos S/A

K052061 MODUS IMF SCREWS 2.0 Medartis, Inc.

Indications for Use Statement

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Mini and Micro Fragments Reconstruction System - NEOFACE is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

MODUS IMF Screws 2.0 are indicated for temporary use as a supplementary method in reduction and fixation of dislocated or fractured bone fragments, condylar fractures and restoration of occlusion in orthognathic or orthodontic procedures.

Screw Designs 2.0 Blocking screw series 2.0 SW3 Blocking screw series Self-drilling thread design

2.0 Blocking screw series 2.0 SH Blocking screw series Self-drilling thread design

2.0 IMF series Self-drilling thread design

Screw diameter 2.0 mm 2.0 mm 2.0 mm

Screw threaded length 5 mm – 14 mm (in 1 mm increments) 5, 7, 9 mm 8, 11, 14 mm

Screw material Ti-6Al-4V alloy Ti-6Al-4V alloy Ti-6Al-4V alloy

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Table 6 – Substantial Equivalence Screws

Subject Device Primary Predicate Device Reference Device Reference Device Reference Device

Comparison

K180204 Mini and Micro Fragments Reconstruction System – CMF Visionare Visionare LLC

K102641 Mini and Micro Fragments Reconstruction System – NEOFACE NEOORTHO Produtos Ortopédicos S/A

K980199 Synthes (USA) 1.5mm/2.0mm Orthognathic Maxillary plates and Screws Synthes (USA)

K972322 Lorenz 1.5mm Neuro Pack/Lorenz 2.0 FT plates (sterile version) Walter Lorenz Surgical, Inc.

K091144 Synthes MatrixMANDIBLE Preformed Reconstruction plates Synthes USA

Indications for Use Statement

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Mini and Micro Fragments Reconstruction System - NEOFACE is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary plates and Screws are generally intended for a variety of pan facial indications. Specifically, they are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Rigid fixation of cranio, facial and neurological bone. The Synthes MatrixMANDIBLE Preformed Reconstruction plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.

Comparison of Screw Designs

Thread Diameter Lengths Thread Diameter Lengths Thread Diameter Lengths Thread Diameter Lengths Thread Diameter Lengths

Non-locking Screws Self-Drilling 1.5 mm 4 mm - 9 mm 1.5 mm 4 mm - 9 mm Self-Tapping 1.5 mm 4 mm – 16 mm 1.5 mm 2.5 mm -16 mm Emergency Self-Tapping 1.8 mm 4 mm – 16 mm 1.8 mm 3.5 mm – 7 mm 1.85 mm 4 mm – 18 mm Self-Drilling 2.0 mm 5 mm – 11 mm 2.0 mm 4 mm – 25 mm Self-Tapping 2.0 mm 4 mm – 19 mm 2.0 mm 4 mm – 19 mm Emergency Self-Tapping 2.3 mm 4 mm – 18 mm 2.3 mm 3.5 mm – 11 mm 2.3 mm 5 mm – 18 mm Self-Tapping 2.4 mm 8 mm – 20 mm 2.4 mm 6 mm – 18 mm 2.4 mm 5 mm – 40 mmEmergency Self-Tapping 2.7 mm 8 mm – 18 mm 2.7 mm 6 mm – 18 mm Locking Screws Self-Tapping Locking 2.0 mm 5 mm – 19 mm 2.0 mm 5 mm – 19 mm Self-Tapping Locking 2.4 mm 8 mm – 20 mm 2.4 mm 6 mm – 18 mm 2.4 mm 8 mm – 24 mmSelf-Tapping Locking 2.7 mm 8 mm – 18 mm 2.7 mm 6 mm – 18 mm Insertion Screws

For Locking plates Threads M2.8x0.4, 1.9 mm L, cruciform head, 2.0 mm Ø

Threads M2.8x0.4, 1.9 mm L, cruciform head, 2.0 mm Ø

Threads M4.0x0.5, 2.5 mm L, cruciform head, 2.4 mm Ø

Threads M4.0x0.5, 2.5 mm L, cruciform head, 2.4 mm Ø

Screw Material Ti-6Al-4V alloy Ti-6Al-4V alloy Ti-6Al-7Nb alloy Ti-6Al-4V alloy Ti-6Al-7Nb alloy

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510(k) Summary K180204 Page 13 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

The subject device 1.5 System plates are substantially equivalent to the primary predicate device K102641, or the reference devices K021624 and K050934, in designs and the range of dimensions. The reference device K021642 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 1.5 Rectangular, Y, Double Y, L Oblique, H, Z, Orbital, and Orbital Floor Plates. The reference device K0050934 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 1.5 T, Y, and L 110° plates. The subject device 2.0 System plates are substantially equivalent to the primary predicate device K102641, or the reference devices K021642, K033065, K972322, K050934, and K080694, in designs and the range of dimensions. The reference device K021642 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.0 Straight, Rectangular, Y, Double Y, L 110°, H, and X plates. The reference device K033065 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.0 Straight Locking and Rectangular Locking plates. The reference device K972322 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.0 Z and Orbital plates. The reference device K050934 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.0 Rectangular, T, L 110°, I, Orbital, and Straight Locking plates. The reference device K080694 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.0 Y plates. The subject device 2.4 System plates are substantially equivalent to the primary predicate device K102641, or the reference devices K091144, K992682, and K063052, in designs and the range of dimensions. The reference device K091144 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.4 Straight Reconstruction, Anatomic Reconstruction, Angled Reconstruction, and Double Angled Reconstruction plates. The reference device K992682 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.4 Anatomic Reconstruction, Angled Reconstruction, and Double Angled Reconstruction plates. The reference device K063052 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.4 Straight Reconstruction and Anatomic Reconstruction plates. The subject device Orthognathic plates are substantially equivalent to the primary predicate device K102641, or the reference devices K980199, K031708, K944565, and K050934, in designs and the range of dimensions. The reference device K980199 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the Orthognathic 110° L, Y, Zygomatic Pillar, Straight Adjustable Sagittal, Y Adjustable Sagittal, and Locking Y Adjustable Sagittal plates. The reference device K031708 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the Orthognathic Y and Le Fort plates. The reference device K944565 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the Orthognathic Le Fort plates. The reference device K050934 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the Orthognathic 110° L, Y, Canine Pillar, Zygomatic Pillar, Le Fort, Chin, Paulus, Straight Sagittal, Straight Adjustable Sagittal, Y Adjustable Sagittal, Locking Straight Sagittal, Locking Straight Adjustable Sagittal, and Locking Y Adjustable Sagittal plates. The subject device Blocking Screws are substantially equivalent to the primary predicate device K102641, or the reference devices K052061 in designs and the range of dimensions. The reference device K052061 is for substantial equivalence of the screw lengths not included in K102641. The subject device

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510(k) Summary K180204 Page 14 of 14 CranioMaxillofacial Fixation (CMF) System – CMF Visionare

blocking screws and the blocking screws from K102641 and K052061 have the same intended use for intermaxillary fixation. The subject device Screws are substantially equivalent to the primary predicate device K102641, or the reference devices K980199, K972322, and K091144 in designs and the range of dimensions. The following subject device screws are substantially equivalent to the primary predicate device K102641 in designs and the ranges of dimensions: 1.5 mm diameter (Ø) self-drilling screws; 1.5 mm Ø self-tapping screws; 2.0 mm Ø self-drilling screws; 2.0 mm Ø self-tapping screws; 2.7 mm Ø self-tapping screws; 2.0 mm Ø self-tapping locking screws; and 2.7 mm Ø self-tapping locking screws. The reference device K980199 is for substantial equivalence of the 1.8 mm Ø self-tapping screw lengths up to 16 mm not included in K102641. The reference device K972322 is for substantial equivalence of the 2.3 mm Ø self-tapping screw lengths up to 18 mm not included in K102641. The reference device K091144 is for substantial equivalence of the 2.4 mm Ø self-tapping screws screw lengths up to 20 mm not included in K102641. The reference device K091144 also is for substantial equivalence of the 2.4 mm Ø self-tapping locking screw lengths up to 20 mm not included in K102641. The subject device insertion screws (for use with locking plates) are substantially equivalent to insertion screws in the primary predicate device K102641 in design and dimensions. All subject device plates are manufactured from commercially pure (CP) titanium and all subject device screws are manufactured from titanium alloy (Ti-6Al-4V); these materials are substantially equivalent to the materials of the primary predicate device K102641. All reference device plates also are manufactured from CP titanium (or Ti-6Al-4V alloy, K080694). The screws from the subject device, the primary predicate K102641, and reference device K972322 screws are manufactured from Ti-6Al-4V alloy. The screws in the reference devices K980199 and K091144 are made of a slightly different Ti-6Al-7Nb alloy; this difference does not affect the intended use or raise different questions of safety or effectiveness. Biocompatibility of the subject device materials was supported by cytotoxicity testing according to according to ISO 10993-5 and ISO 10993-12. Performance data provided to demonstrate substantial equivalence included detailed dimensional analysis of the subject device and predicate/reference device designs, engineering analysis, and mechanical testing of the subject device according to ASTM F382 (single cycle bending and bending fatigue) and ASTM F543 (torsional properties, driving torque, axial pullout, self-tapping performance). Comparisons of the cross-sectional dimensions and calculation of the bending moments of inertia (Ix, Iy) were performed on critical regions of minimum material cross section subject to bending. The moment of inertia calculations take into consideration the geometry and provide an assessment of the worst-case scenario for the subject and predicate constructs. In this engineering analysis the subject device plates compared favorably to the predicate/reference devices. CONCLUSION

The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device, the primary predicate device, and the reference devices encompass the same range of physical dimensions, are provided non-sterile, and are to be sterilized by using moist heat (steam) sterilization. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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