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Xpert 2.4

Cost eff ic ienc y

Surgeon

HOSPITAL

Calling on medical staff

Defective sterilization

Incomplete kit

Damaged instrumentation

Complex traceability

Contracted out sterilization

Suppliers’ deadline

Constraints

H igh costs

Complex pro cess

Stocks

Control

Cleaning

Decontamination

Sterilization

Bulky storage

1Delivery

5Deconta-mination

9Packaging of the kit

13Cleaning

17Restocking

2Storage

6Cleaning

10Sterilization

14Drying

18Packaging of the kit

3Unpacking

7Drying

11Surgery

15Control

19Sterilization

4Control

8Control

12Deconta-mination

16Traceability

20Storage

NON OPTIMALsurgery

INCREASED RISKS

With a non sterilestandard kit

Prevents an effective solution & a quick response

URGENT SURGICAL CASES COMPROMISED

Incomplete kit

S afet y

Cost eff ic ienc y Eff ic ienc y

Available when needed

An effective solution &a quick response

TRACEABILITYRisk of contamination

Optimized storage

1Delivery

2Storage

3Surgery

READY-TO-USE FOR SURGERY

Optimized handling ofURGENT SURGICAL CASES

Sundry expenses

Surgeon

Hospital

Cleaning

Decontamination

Sterilization

Controlled stockscontrolSimplified

with state-of-the-art implants

With the

kit

™

Xpert 2.4

Available when needed:The Initial R™ Xpert 2.4 kit comes pre-sterilized and ready to use.The combination of sterile implants and single use instrumentation in a single packaging makes Initial R™ Xpert 2.4 ideal for use in urgent surgical cases.

Storage: Initial R™ Xpert 2.4 kit can be easily stored in the operating room because of its small size.

Costs: Initial R™ Xpert 2.4 is a cost-effective solution.The additional costs including cleaning, decontamination, sterilization of kits are cancelled.

Safety:The Initial R™ Xpert 2.4 kit is fully traceable and has a shelf life of 5 years.Its instrumentation and implants are “always new” and have never been opened or used before.

Contamination:The combination of sterile implants and sterile single-use instrumentation minimizes contamination risks.

™

innovation

Buying procedure:Initial R™ Xpert 2.4 facilitates buying procedures: restocking and orders are simplified, stock management is optimized.

Initial R™ Xpert 2.4 kits Kit content

IndicationsThe implants of the Initial R™ Xpert 2.4 wrist range are intended for hand and forearm fractures, osteotomies and arthrodeses in adults.

Contraindications• Serious vascular deterioration, bone devitalization.• Pregnancy.• Acute or chronic local or systemic infections.• Lack of musculo-cutaneous cover, severe vascular deficiency affecting the concerned area.• Insufficient bone quality preventing a good fixation of the implants into the bone.• Muscular deficit, neurological deficiency or behavioral disorders, which could submit the implant to abnormal mechanical

strains.• Allergy to one of the materials used or sensitivity to foreign bodies.• Serious problems of non-compliance, mental or neurological disorders, failure to follow post-operative care

recommendations.• Unstable physical and/or mental condition.

SDT2.4LxxØ2.4 mm locking screws

Non anodized

Pins - Ø1.4 L120 mm x4

T8 prehensor screwdriver

Length gaugePolyaxial drill guide

Handle for guide gauge

CT2.4LxxØ2.4 mm standard cortical screws pink anodized

Ø1.8 mm threaded guide gauge

Ø1.8 mm quick coupling drill bit - L125 mm

Plate for distal radius fracture

Sizes 1 & 2

The window in the plate allows a better visualization of the fracture reduction or for a bone graft insertion

Hole for pin insertion to locate the joint space

1st distal screw row to support the volar lip

2nd distal screw row to support the dorsal lip

Locking oblong hole allows to adjust the plate positioning with a cortical screw; in case of poor bone quality, a locking screw can be used to increase stability.

Reduced distal profile to limit contact with tendons

8 polyaxial holes for size 1 and 9 for size 2

Holes for Ø1.4 mm pin

Distal 32.1°Ulnar 5.9°


Distal 24°Ulnar 3.8°

Distal 26°Radial 1.1°

Distal 38.7°Radial 12.7°

Distal 38.7°Radial 12.7°

Reference point 0°

Pre-angled holes

A comprehensive range of plates

Kits available for 6 sizes (3 lengths and two head shapes) of plates for the right (green plates) and left (blue plates) sides offering versatile solutions.

Dedicated instruments for mini invasive (MIS) surgery are available for these implants.

Initial R™ Xpert 2.4 kits Technical features

Size 1 Size 2 Size 3

Size 1 Size 2 Size 3

8 polyaxial holes

Holes for Ø1.4 mm pin

Hole for pin insertion to locate the joint space

Locking oblong hole allows to adjust the plate positioning with a cortical screw; in case of poor bone quality, a locking screw can be used to increase stability

Reduced distal profile to limit contact with tendons

2 pre-angled monoaxial locking holes targeting the radial styloid

Monoaxial fixation only using the threaded guide gauge for :

Window’s monoaxial locking hole

Size 3

The window in the plate allows a better visualization of the fracture reduction or for a bone graft insertion

Pre-angled holesInitial R™ Xpert 2.4 kits Technical features



Distal 24°Ulnar 3.8°

Distal 26°Radial 1.1°Distal 62.5°Radial 30.2°Distal 61.5°Radial 28.9°Radial 0°Distal 37°

Reference point 0°Plate dedicated to target the radial styloid tip

Plate features

ANATOMICAL SHAPE AND LOW PROFILE

The design of these implants is the result of a proprietary state-of-the-art mapping technology to etablish the maximum congruence between the plate and the bone.

• Precontoured plates for a distal anatomical fit :

- The distal edge of the plate runs alongside the watershed line

- Different medial and lateral radii of curvature for optimized volar tilt

• Low overall profile height and chamfered plate contour to reduce the tendons and soft tissues irritation.

• Various pin holes possibilities: to locate the joint space or to temporarily fix specific fragments.

• Multiple points of fixation and the ability to reach small fragments (dorsal lip comminution), allowing to treat highly comminutive fractures.

Screw and fixation features

• Ø 2.4 mm locking screws: unique diameter for an intra operative time saving.

• Hexalobular screw head design (Improved torque transmission – Optimized pick and stick).

• Optimized screw head design limiting protuberance and soft tissue irritation.

• Pre-angled holes for optimized screw placement thanks to the use of the threaded guide gauge.

• New patented polyaxial locking platform +/-10° thanks to the use of the polyaxial drill guide. Help reducing the sigmoid notch and lunate facet.

• Smooth tip preventing soft tissue irritation.

• Screw length from 10 to 28 mm.

When using the polyaxial drill guide, make sure that the guide is inserted in the axis of the hole to avoid over angulation of the drilling, which could result in a failure of the locking mechanism.

POLYAXIAL AND MONOAXIAL LOCKING FIXATION – Ø2.4 MM LOCKING SCREWS

Initial R™ Xpert 2.4 kits Technical Features

Hexalobular stamp

Volar tilt

+/- 10 °

Watershed line

Ref : DTDVS3

Handle for guide gauge. Before performing the drilling into the oblong hole, snap the handle for guide gauge on the Ø1.8 mm threaded guide gauge.

OPTIMIZED SCREW POSITIONING TO RESTORE BONE ANATOMY

• Pre-oriented screws targeting the tip of the radial styloid for an optimized support to establish fracture reduction (only for the Ø2.4 mm size 3 plates (DTxVS3 and DTxVN3).

• Anatomically distributed screws following the subchondral bone to secure distal fragments.

• 2 rows of subchondral support to increase the stability of the reduction:

> 1st row with 4 locking screws to support the volar lip,

> 2nd row with 3 locking screws to support the dorsal lip.

Templates

The Initial R™ Xpert 2.4 templates have been designed to determine quickly and simply the appropriate Initial R™ Xpert 2.4 kit. Each kit has its own template. Templates are divided into 6 distinct groups (see table below).

* Available in sterile packaging - Single use kit.

LOCKING OBLONG HOLE – Ø2.4 MM LOCKING AND NON LOCKING SCREWS

• Based on the surgical technique, cortical screws can be used either to finalize the reduction by creating compression or to stabilize the plate.

• In case of poor bone quality, the use of a locking screw can increase the stability.

Initial R™ Xpert 2.4 kits Initial R™ Xpert 2.4 templates

Ref : DTDVS3

ANC942 ANC943 ANC944 ANC945

ANC949 ANC950

Each template is marked to easily identify the corresponding Initial R™ Xpert 2.4 kit.

STERILE TEMPLATES*

Ref. Description

ANC942 Single use templates for KIT-XN1D and KIT-XS1D

ANC943 Single use templates for KIT-XN1G and KIT-XS1G

ANC944 Single use templates for KIT-XS2D and KIT-XN2D

ANC945 Single use templates for KIT-XS2G and KIT-XN2G

ANC949 Single use templates for KIT-XS3D and KIT-XN3D

ANC950 Single use templates for KIT-XS3G and KIT-XN3G

1. Determine the plate size thanks to the templates, then choose the suitable kit. Afterward, stabilize the fracture, then position the plate.

2. Snap the handle for guide gauge on the Ø1.8 mm threaded guide gauge and perform the drilling using the assembly in the oblong hole.

Option 1 - Determine the screw length using the drill bit and guide gauge.

Option 2 - Determine the screw length using the length gauge.

Proceed with the monoaxial technique* for the remaining locking

holes. (* The polyaxial technique can be

performed in all the holes if needed).

4. Insert a Ø1.4 mm pin into the most distal hole for pin and check the joint space.

Then remove the pin.

Insert the polyaxial drill guide into the radioulnar hole (1) and drill. Determine the screw length using the length gauge and insert a Ø2.4 mm non-anodized locking screw using the screwdriver. Proceed similarly with the lateral hole positioned near the radial styloid process (2)

Insert the guide gauge into the radioulnar hole (1) and drill using the drill bit. Option 1 - Determine the screw length

using the drill bit and guide gauge.


Then, insert a Ø2.4 mm non anodized locking screw using the screwdriver.

3. Insert the Ø2.4 mm pink cortical screw into the oblong hole to hold the plate.

NB: In case of poor bone quality, a Ø2.4 mm locking screw (SDT2.4Lxx) can be inserted to increase stability.

Polyaxial technique Monoaxial technique

Example: surgical technique with a standard plate or narrow plate size 1 and 2.

Step 5

or

Initial R™ Xpert 2.4 kits Surgical techniques

FINAL RESULT

Option 1

Option 2

Option 1

Option 2

(1)

(2)

Example: surgical technique with a standard plate or narrow plate size 3.

1. Determine the plate size thanks to the templates, then choose the suitable kit. Afterward, stabilize the fracture, then position the plate.

4. Insert a Ø1.4 mm pin into the most distal hole for pin and check the joint space.

Then remove the pin.

2. Snap the handle for guide gauge on the Ø1.8 mm threaded guide gauge and perform the drilling using the assembly in the oblong hole.

Option 1 - Determine the screw length using the drill bit and guide gauge.


Insert the polyaxial drill guide into the radioulnar hole (1) and drill using the drill bit. Determine the screw length using the length gauge.

Insert the guide gauge into the radioulnar hole (1) and drill using the drill bit. Option 1 - Determine the screw length using

the drill bit and guide gauge.Option 2 - Determine the screw length using

the lenght gauge.

Proceed with the monoaxial technique (or polyaxial technique if need be) for the remaining locking

holes.

3. Then, insert the Ø2.4 mm pink cortical screw into the oblong hole to hold the plate.

NB: In case of poor bone quality, a Ø2.4 mm locking screw (SDT2.4Lxx) can be inserted to increase stability.

Then, insert a Ø2.4 mm non anodized locking screw using the screwdriver. The use of the threaded guide gauge is compulsory for the 2 lateral holes positioned near the radial styloid process and the window’s locking hole (2).

Polyaxial technique Monoaxial techniqueStep 5

or

or

Initial R™ Xpert 2.4 kits Surgical techniques

(1)

(2)

FINAL RESULT

Option 1

Option 2

Option 1

(1)

(2)

Option 2

NB : Supplemental screws are available in sterile packaging (cf. : Initial R™ Xpert 2.4 additional kits, additional implants)

Initial R™ Xpert 2.4 kits References

INITIAL R™ XPERT KITS

Ref. Description

KIT-XS1G Distal radius kit - Standard head - Size 1 - Left

KIT-XS1D Distal radius kit - Standard head - Size 1 - Right





KIT-XN1G Distal radius kit - Narrow head - Size 1 - Left

KIT-XN1D Distal radius kit - Narrow head - Size 1 - Right





INITIAL R™ XPERT KITS - IMPLANTS CONTENT QUANTITY PER KIT

Ref. Description KIT-XS1G or KIT-XS1D

KIT-XS2G or KIT-XS2D

KIT-XS3G or KIT-XS3D

KIT-XN1G or KIT-XN1D



STANDARDPLATES

DTGVS1 or DTDVS1

2.4 Polyaxial plate for distal radius - Standard head - Size 1 - Left or Right 1 - - - - -

DTGVS2 or DTDVS2

2.4 Polyaxial plate for distal radius - Standard head - Size 2 - Left or Right - 1 - - - -

DTGVS3 or DTDVS3

2.4 Polyaxial plate for distal radius - Standard head - Size 3 - Left or Right - - 1 - - -

NARROW PLATES

DTGVN1 or DTDVN1

2.4 Polyaxial plate for distal radius - Narrow head - Size 1 - Left or Right - - - 1 - -

DTGVN2 or DTDVN2

2.4 Polyaxial plate for distal radius - Narrow head - Size 2 - Left or Right - - - - 1 -

DTGVN3 or DTDVN3

2.4 Polyaxial plate for distal radius - Narrow head - Size 3 - Left or Right - - - - - 1

LOCKING SCREWSØ2.4 MM

SDT2.4L12 Locking screw with conical head - Ø2.4 mm - L 12 mm - 1 2 2 2 3

SDT2.4L14 Locking screw with conical head - Ø2.4 mm - L 14 mm 2 2 2 2 3 3

SDT2.4L16 Locking screw with conical head Ø2.4 mm - L 16 mm 2 2 2 2 3 3



SDT2.4L22 Locking screw with conical head Ø2.4 mm - L 22 mm 2 2 2 - - 1

SDT2.4L24 Locking screw with conical head Ø2.4 mm - L 24 mm - - 1 - - -

STANDARD CORTICAL SCREWSØ2.4 MM

CT2.4L12 Standard cortical screw Ø2.4 mm - L 12 mm - - - - 1 1

CT2.4L14 Standard cortical screw Ø2.4 mm - L 14 mm - 1 1 1 1 1

CT2.4L16 Standard cortical screw Ø2.4 mm - L 16 mm 1 1 1 1 - -

CT2.4L18 Standard cortical screw Ø2.4 mm - L 18 mm 1 - - - - -

INITIAL R™ XPERT KITS - INSTRUMENTATION CONTENT

Description Qty

Pins - Ø1.4 L 120 mm 4

T8 prehensor screwdriver 1

Length gauge 1

Ø1.8 mm quick coupling drill bit - L 125 mm 1

Handle for guide gauge 1

Ø1.8 mm threaded guide gauge 1

Polyaxial drill guide 1

Removal and rescue kits Sterile instruments

Additional implants Sterile screws packaged in the Supplemental sterile screw caddy

The information presented in this brochure is intended to demonstrate a Newclip Technics product. Always refer to the package insert, product label and/or user instructions before using any Newclip Technics product. Surgeons must always rely on their own clinical judgment when de-ciding which products and techniques to use with their patients. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Newclip Technics representative if you have questions about the availability of Newclip Technics products in your area.

Initial R™ Xpert 2.4 kits References

Supplemental instrumentation kits

REMOVAL AND RESCUE KITS

Ref. Description Content

KIT-REMOVE-2 Removal kit for T8 hexalobe - T8 prehensor screwdriver

KIT-RESCUE-5 Rescue kit for Ø2.4mm screws - Handle for guide gauge- Length gauge - Ø1.8 mm quick coupling drill bit - L 125 mm- Polyaxial drill guide- Ø1.8 mm threaded guide gauge- 4 x Pin Ø1.4 L120 mm

LOCKING SCREWS - Ø2.4 mm*

Ref. Description Qty

SDT2.4L10-ST Locking screw with conical head - Ø2.4 mm - L 10mm - STERILE 2

SDT2.4L12-ST Locking screw with conical head - Ø2.4 mm - L 12 mm - STERILE 2









STANDARD CORTICAL SCREWS - Ø2.4 mm*

Ref. Description Qty

CT2.4L10-ST Standard cortical screw - Ø2.4 mm - L 10 mm - STERILE 1










NEWCLIP TECHNICSPA de la Lande Saint Martin45 rue des Garottières, FranceTél. : +33 (0)2 28 21 23 25 - Fax : +33 (0)2 40 63 68 [email protected] www.newcliptechnics.com

NEWCLIP USA642 Larkfield Center Santa Rosa CA 95403, USAPhone : + 1 707 230 5078 [email protected]

NEWCLIP TECHNICS GmbHPröllstraße 11D-86157 Augsburg, DeutschlandPhone : +49 (0)821 650 749 40 [email protected]

NEWCLIP TECHNICS Australia Forest Central Business Park, Building 10 Level 1, 49 Frenchs Forest Rd, Frenchs Forest 2086, AustraliaPhone: +61 (0)2 81 886 [email protected] Br

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™

Xpert 2.4

KIT-XS3G

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