X-spine Surgical Technique

X-spineSM Surgical Technique

IRIX-A™ Lumbar Integrated Fusion System

Index

INSTRUCTIONS FOR USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

IMPLANTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

IRIX-A™ LUMBAR INTEGRATED FUSION SYSTEM SURGICAL TECHNIQUE

Patient Positioning and Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Endplate Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Implant Sizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Implant Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Implant Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Implant Insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Screw Hole Preparation and Screw Insertion . . . . . . . . . . . . . . . . . . . . . 17

System Removal or Revision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

INSTRUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

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X-spine Systems, Inc. Irix-A™ Lumbar Integrated Fusion System

Y IMPORTANT NOTE:

The user acknowledges that he/she has read and agreed to the condi�ons in this insert, which are to be considered as contractual.

GENERAL INFORMATION

The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the lumbar spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the device. The Irix-A implant is manufactured from both �tanium alloy (Ti6AI4V) in accordance with ASTM F136 and Invibio PEEK Op�ma LT1 in accordance with ASTM F2026, or from Ti6Al4V �tanium alloy alone. The device will be supplied with the op�on of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure �tanium (CP Ti) per ASTM F1580. The device is then secured in loca�on through the use of bone screws, also manufactured from �tanium alloy (Ti6AI4V) per ASTM F136. The devices are provided in various sizes and screws are offered in mul�ple lengths to adjust for varia�ons in pa�ent anatomy.

INDICATIONS FOR USE

The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in pa�ents with degenera�ve disc disease (DDD) at one (1) or two (2) con�guous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin with degenera�on of the disc confirmed by history and radiographic studies. These pa�ents should be skeletally mature and have had at least six (6) months of non-opera�ve treatment. In addi�on, these pa�ents may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Irix-A System is intended to be used with autogenous bone gra� material, and is to be used with three �tanium alloy screws included as part of the system.

CONTRAINDICATIONS

Contraindica�ons for the Irix-A Lumbar Integrated Fusion System are similar to those of other systems of similar design, and include, but are not limited to:

1. Pa�ents with probable intolerance to the materials used in the manufacture of this device. 2. Pa�ents with infec�on, inflamma�on, fever, tumors, elevated white blood count, obesity, pregnancy,

mental illness and other medical condi�ons which would prohibit beneficial surgical outcome. 3. Pa�ents resistant to following post-opera�ve restric�ons on movement, especially in athle�c and

occupa�onal ac�vi�es. 4. Use with components from other systems or manufacturers. 5. Grossly distorted anatomy caused by congenital abnormali�es. 6. Any other medical or surgical condi�on which would preclude the poten�al benefit of spinal implant

surgery.

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INSTRUCTIONS FOR USE

7. Rapid joint disease, bone absorp�on, osteopenia. Osteoporosis is a rela�ve contraindica�on since this condi�on may limit the degree of obtainable correc�on, stabiliza�on, and/or the amount of mechanical fixa�on.

8. Any case where the implant components selected for use would be too large or too small to achieve a successful result.

9. Any pa�ent having inadequate �ssue coverage over the opera�ve site or inadequate bone stock or quality. 10. Any pa�ent in which implant u�liza�on would interfere with anatomical structures or expected

physiological performance. 11. Any case not described in the indica�ons for use. 12. Reuse or mul�ple uses. 13. Prior fusion at the level(s) to be treated.

Y WARNINGS

Poten�al risks associated with the use of this system, which may require addi�onal surgery, include; device component neurological injury, and vascular or visceral injury. Discard all damaged or mishandled implants. Never reuse an implant, even though it may appear undamaged.

Internal fixa�on devices cannot withstand ac�vity and load levels equal to those placed on normal healthy bone. Un�l matura�on of the fusion mass is confirmed, do not subject this device to the stress of full weight bearing, or implant failure may result.

Contouring and bending of a system component may reduce its fa�gue strength and cause failure under load. If spinal screws are bent or otherwise damaged during inser�on or adjustment, the screw should be explanted and replaced.

Mixing Metal; some degree of corrosion occurs on all implanted metal alloys. Contact of dissimilar metals, however, may accelerate this corrosion process. The presence of corrosion may accelerate fa�gue fracture of implants, and the amount of metal compounds released into the body system will also increase. Internal fixa�on devices, such as rods, hooks, screws, etc. which come in contact with other metal objects, must be made from like or compa�ble metals. Because different manufacturers employ different materials, varying tolerances and manufacturing specifica�ons, and differing parameters, the components of Irix-A should not be used in conjunc�on with components from any other manufacturer’s spinal system.

PRECAUTIONS

As with any surgical system the Irix-A Lumbar Integrated Fusion System should be used by experienced surgeons with specific training in the use of the spinal system because this is a technically demanding procedure presen�ng a risk of serious injury to the pa�ent.

Knowledge of surgical techniques, proper reduc�on, selec�on and placement of implants, and pre- and post-opera�ve pa�ent management are considera�ons essen�al to a successful surgical outcome. Appropriate selec�on, placement and fixa�on of the spinal system components are cri�cal factors which affect implant service life. As in the case of all prosthe�c implants, the durability of these components is affected by numerous biologic, biomechanics and other extrinsic factors, which limit their service life. Accordingly, strict adherence to the indica�ons, contraindica�ons, precau�ons, and warnings for this product is essen�al to poten�ally maximize

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service life. (Note: While proper implant selecon can minimize risks, the size and shape of human bones present limitaons on the size, shape, and strength of the implants).

Paents who smoke have been shown to have an increased incidence of pseudoarthrosis. Such paents should be advised of this fact and warned of the potenal consequences. Paents with previous spinal surgery at the level to be treated may have different clinical outcomes compared to those without a previous surgery. Based on the fague tesng results, the physician/surgeon should consider the level of implantaon, paent weight, paent acvity level, and other paent condions, etc. which may have an impact on the performance of the system.

If the paent is involved in an occupaon or acvity which applies inordinate stress upon the implant (e.g. substanal walking, running, li�ing, or muscle strain) resultant forces can cause failure of the device. In some cases, progression of degenerave disease may be so advanced at the me of implantaon that the expected useful life of the appliance may be substanally decreased. In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief. Paents should be instructed in detail about the limitaons of the implants, including, but not limited to, the impact of excessive loading through paent weight or acvity, and be taught to govern their acvies accordingly. The paent should understand that a metallic implant is not as strong as normal, healthy bone and will bend, loosen or fracture if excessive demands are placed on it. An acve, debilitated, or demented paent who cannot properly use weight supporng devices may be parcularly at risk during postoperative rehabilitaon.

Care must be taken to protect the components from being marred, nicked or notched as a result of contact with metal or abrasive objects. Alteraons will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant.

As with all orthopedic and neurosurgical implants, none of the Irix-A Lumbar Integrated Fusion System components should ever be reused under any circumstances. Risks associated with reuse include infecon, non-union (pseudarthrosis), serious paent injury or death.

Due to the presence of implants, interference with roentgenographic, CT and/or MR imaging may result. The Irix-A Lumbar Integrated Fusion System has not been evaluated for safety and compability in the MR environment. The Irix-A Lumbar Integrated Fusion System has not been tested for heang or migraon in the MR environment. It must be noted that there are several different manufacturers and generaons of MRI systems available, and X-spine cannot make any claims regarding the safety of X-spine implants and devices with any specific MR system.

Physician Note: The physician is the learned intermediary between the company and the paent. The indicaons, contraindicaons, warnings, and precauons given in this document must be conveyed to the paent. If requested, addional informaon, including surgical technique manuals, may be obtained through corporate sales representaves.

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5. Device components should be received and accepted only in packages that have not been damaged or tampered with. Damaged implants and/or instruments should not be used. Components must be carefully handled and stored in a manner that prevents scratches, damage, and corrosion.

6. The type of implant to be used for the case should be determined prior to beginning the surgery. 7. All parts should be cleaned and sterilized before use.

INTRAOPERATIVE MANAGEMENT

1. Extreme cau on should be used around the spinal cord and nerve roots. Damage to these structures will cause loss of neurological func on.

2. Breakage, slippage, or misuse of instruments or implant components may cause injury to the pa ent or opera ve personnel.

3. Whenever possible or necessary, an imaging system should be u lized to facilitate surgery. 4. Cau on should be taken in handling the implants; Damage to the implants may affect their performance. 5. Implants should not be reused under any circumstances.

INSTRUCTIONS FOR USE For complete instruc ons regarding the proper use and applica on of all Irix-A implants and instruments, please refer to the Irix-A Surgical Technique Manual (available at no charge upon request).

POSTOPERATIVE MANAGEMENT

Postopera ve management by the surgeon, including instruc on and warning to and compliance by the pa ent, of the following is essen al:

1. The pa ent should have a complete understanding of and compliance with the purpose and limita ons of the implant devices.

2. Postopera ve pa ents should be instructed to limit ac vity. 3. Rigid external orthosis/bracing should be u lized un l fusion is confirmed clinically and radiographically. 4. If required, the device may be disassembled for explanta on. Care should be taken to avoid damaging the

implant and surrounding ssue as li�le as possible. The explanted device should be cleaned and disinfected using the instruc ons provided for cleaning/disinfection of instruments. Informa on on the procedure and pa ent should be retained to assist in any inves ga on.

5. Retrieved implants should be properly disposed of and are not to be reused under any circumstances.

PREOPERATIVE MANAGEMENT

1. The surgeon should consider for surgery only those pa ents indicated for the use of this device. 2. The surgeon should not consider for surgery those pa ents contraindicated for the use of this device. 3. The surgeon should have a complete understanding of the device's indica ons, contraindica ons, and

applica ons. 4. The surgeon should have a complete understanding of the func on and limita ons of each implant and

instrument.

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7. Loss of neurological func�on including paralysis (par�al or complete), radiculopathy, and/or the development or con�nua�on of pain, numbness, spasms, or sensory loss.

8. Cauda equina syndrome, neurological deficits, paraplegia, reflex deficits, irrita�on, and/or muscle loss. 9. Loss of bladder control or other types of urological system compromise. 10. Scar forma�on possibly causing neurological compromise or compression around nerves and/or pain. 11. Fracture, micro-fracture, resorp�on, damage, or penetra�on of any spinal bone. 12. Herniated nucleus pulposus, disc disrup�on or degenera�on at, above, or below the level of surgery. 13. Non-union (pseudarthrosis), delayed union, mal-union. 14. Cessa�on of any poten�al growth of the operated por�on of the spine. 15. Loss of or increase in spinal mobility or func�on. 16. Inability to perform the ac�vi�es of daily living. 17. Death.

POTENTIAL COMPLICATIONS AND ADVERSE SIDE EFFECTS

Poten�al complica�ons and adverse effects for this system are similar to those of other spinal instrumenta�on systems, and include, but are not limited to:

1. Early or late loosening of any or all of the components. 2. Disassembly, bending, and/or breakage of any or all of the components. 3. Foreign body (allergic) reac�on to implants. 4. Post-opera�ve change in spinal curvature, loss of correc�on, height, and/or reduc�on. 5. Infec�on. 6. Dural tears, persistent CSF leakage, meningi�s.

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PACKAGING, LABELING, AND STORAGE

The spacers of the Irix-A Lumbar Integrated Fusion System are supplied clean and STERILE. The spacers are delivered packaged in double-wrapped Tyvek/PET pouches, boxed and individually labeled. The spacers may be delivered individually or in a complete set. Boxes and pouches should be inspected for damage that may affect the integrity of the sterile packaging prior to use.

The screws and accompanying instruments of the Irix-A System are supplied clean and NON-STERILE. They must be sterilized prior to use (see below). The implants may be delivered in packages that must be intact at the �me of receipt. The implants may be delivered as a complete set: Implants and instruments are contained within specially designed trays or in boxes which can be sterilized directly. Use care in handling and storage of the implant components. Cu�ng, sharply bending, or scratching the surface can significantly reduce the strength and fa�gue resistance of the implant system. This, in turn, could induce cracks and/or non-visible internal stresses that could lead to fracture of the implants. Implants and instruments in storage should be protected from corrosive environments such as salt, air, moisture, etc. Inspec�on and trial assembly are recommended prior to surgery to determine if instruments or implants have been damaged during the storage processes.

STERILIZATION

Irix-A Lumbar Integrated Fusion System screws and all instruments are provided non-sterile and must be sterilized before use. All implants and instruments must be free of packaging material and bio-contaminants prior to steriliza�on. To achieve a sterility assurance level of not less than 10-6, all non-sterile implants and instruments should be autoclave sterilized using the following validated cycle parameter:

Saturated steam method, pre-vacuum air removal, 270o F (132o C), 4-minute minimum exposure �me, 30-minute minimum drying �me, in a double–wrapped case configura�on.

It is the end user’s responsibility to use only sterilizers and accessories (such as steriliza�on wraps, steriliza�on pouches, chemical indicators, biological indicators, and steriliza�on casse�es) that have been cleared by the U.S. Food and Drug Administra�on.

CLEANING OF INSTRUMENTS

Y Cau�on: Use of sodium hydroxide (NaOH) is prohibited. Use of corrosive products and/or instruments

including abrasive sponges and metal brushes should be avoided. Cleaning must be performed by personnel trained in the general procedures involving contaminant removal. Automated washer/disinfector systems are not recommended as the sole cleaning method for surgical instruments. An automated system may be used in addi�on to the following manual cleaning procedure.

1. Thoroughly clean all instruments prior to use and as soon as possible a er use (within a maximum of 2 hours post-opera�on) with intensive rinsing under cool tap water (<40°C) to remove gross soil. Do not allow blood and debris to dry on the instruments. If cleaning must be delayed, place instruments in a covered container with appropriate detergent (Enzol® Enzyma�c Detergent or equivalent) to delay drying.

2. No instruments within this system require disassembly as part of the cleaning process. 3. The following table describes the required steps for thoroughly cleaning the system instruments:

Step Agent

Minimum Time (mm:ss)

Instruc�ons

1. Ini�al Clean

Enzol Enzyma�c Detergent Solu�on (or equivalent)

10:00

Add one (1) ounce (30 mL) of Enzol to one (1) gallon (3.8 L) of tap water. Soak instruments immediately a er use and flush detergent through all channels un�l evidence of organic material is removed. Soak for a minimum of ten (10) minutes. Use a so bristle brush (Spectrum™ M-16 or equivalent) to gently remove visible debris. Pay close a�en�on to threads, crevices, lumens and hard to reach areas. If organic material is dried-on, extend soak �me and use two (2) ounces (60 mL) of Enzol per one (1) gallon (3.8 L) of warm tap water.

2. Rinse

Deionized water 3:00

Thoroughly rinse each instrument with deionized water including all channels to remove detergent for a minimum of three (3) minutes.

3. Inspec�on

Unaided eye 1:00

Inspect each instrument for evidence of organic material. Par�cular a�en�on should be taken to remove all debris from instruments with cannula�ons, holes, and features that may be shielded from brushing ac�on. Subject instruments to ultrasonic cleaning if organic ma�er is present a er the ini�al cleaning step.

4. Ultrasonic

Enzol Enzyma�c Detergent Solu�on (or equivalent)

10:00

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Clean (if required)

Prepare a fresh solu�on by adding one (1) ounce (30 mL) of Enzol and one (1) gallon (3.8 L) of warm tap water to a sonica�on unit (Branson Bransonic® Ultrasonic Cleaner or equivalent). Fully immerse the instruments in the solu�on and sonicate for a minimum of ten (10) minutes.

5. Ultrasonic

Rinse


Thoroughly rinse each instrument with deionized water including all holes and cannula�ons to remove detergent for a minimum of three (3) minutes.

6. Inspec�on

Unaided eye 1:00

Inspect each instrument for evidence of organic material. Repeat the ultrasonic clean and rinse steps if needed.

4. Upon comple�on, visually inspect each instrument for contamina�on such as remaining soil and moisture or wetness. If soil remains, repeat the cleaning process. If wetness remains, use filtered pressurized air or lint-free wipes to dry.

INSPECTION

Repeated processing according to the instruc�ons in this document has minimal effect on the reusable instruments. End of life is determined by wear and damage due to the intended surgical use and not to reprocessing. Instruments must be inspected a�er reprocessing to ensure proper func�on of the instrumenta�on.

1. Carefully inspect each instrument to ensure all visible blood and soil has been removed. 2. Inspect instruments and instrument cases for damage. Check ac�on of moving parts to ensure proper

opera�on. All markings should be legible. 3. If damage or wear is noted that may compromise the proper func�on of the instrument or instrument case,

do not use and contact customer service or your X-spine Systems representa�ve for a replacement. 4. If other signs of unacceptable wear and tear are noted (such as corrosion, pi�ng, cracking, etc.), do not use

and contact customer service or your X-spine Systems representa�ve for a replacement.

CAUTION: Federal Law (USA) restricts these devices to use by or on the order of a physician.

Manufacturer:

M X-spine Systems, Inc.452 Alexandersville Rd.Miamisburg, OH 45342 USAPhone: (800) 903-0640Fax: (937) 847-8410

Y CAUTION: Federal Law (USA) restricts these devices to use by or on the order of a physician.

Part Number X080-2003 B

10

Clean (if required)

Prepare a fresh solu�on by adding one (1) ounce (30 mL) of Enzol and one (1) gallon (3.8 L) of warm tap water to a sonica�on unit (Branson Bransonic® Ultrasonic Cleaner or equivalent). Fully immerse the instruments in the solu�on and sonicate for a minimum of ten (10) minutes.

5. Ultrasonic

Rinse


Thoroughly rinse each instrument with deionized water including all holes and cannula�ons to remove detergent for a minimum of three (3) minutes.

6. Inspec�on

Unaided eye 1:00

Inspect each instrument for evidence of organic material. Repeat the ultrasonic clean and rinse steps if needed.

4. Upon comple�on, visually inspect each instrument for contamina�on such as remaining soil and moisture or wetness. If soil remains, repeat the cleaning process. If wetness remains, use filtered pressurized air or lint-free wipes to dry.

INSPECTION

Repeated processing according to the instruc�ons in this document has minimal effect on the reusable instruments. End of life is determined by wear and damage due to the intended surgical use and not to reprocessing. Instruments must be inspected a�er reprocessing to ensure proper func�on of the instrumenta�on.

1. Carefully inspect each instrument to ensure all visible blood and soil has been removed. 2. Inspect instruments and instrument cases for damage. Check ac�on of moving parts to ensure proper

opera�on. All markings should be legible. 3. If damage or wear is noted that may compromise the proper func�on of the instrument or instrument case,

do not use and contact customer service or your X-spine Systems representa�ve for a replacement. 4. If other signs of unacceptable wear and tear are noted (such as corrosion, pi�ng, cracking, etc.), do not use

and contact customer service or your X-spine Systems representa�ve for a replacement.

CAUTION: Federal Law (USA) restricts these devices to use by or on the order of a physician.

Manufacturer:

M X-spine Systems, Inc.452 Alexandersville Rd.Miamisburg, OH 45342 USAPhone: (800) 903-0640Fax: (937) 847-8410

Y CAUTION: Federal Law (USA) restricts these devices to use by or on the order of a physician.

Part Number X080-2003 B

IRIX-ATM IMPLANTS

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Screw orientation 35° cephalad/caudal with up to 6° conical screw angulation

Integrated Titanium Ring provides better x-ray visibility

Locking arm provides tactile, visual and audible feedback

Titanium Plasma Coated (PC) PEEK provides fluoroscopic endplate visualization

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Item # DescriptionX080-332611-08PC-STR 33 X 26 X 8°, 11mm, PC (Sterile)

X080-332613-08PC-STR 33 X 26 X 8°, 13mm, PC (Sterile)









Irix-A™ 33mm x 26mm Implants












Item # DescriptionX080-5525SD 5.5 X 25mm, Self-Drilling Screw

X080-5530SD 5.5 X 30mm, Self-Drilling Screw



Self-Drilling Screws

Item # DescriptionX080-5525ST 5.5 X 25mm, Self-Tapping Screw

X080-5530ST 5.5 X 30mm, Self-Tapping Screw



Self-Tapping Screws

Item # DescriptionX080-6025 6.0 X 25mm, Self-Tapping Rescue Screw

X080-6030 6.0 X 30mm, Self-Tapping Rescue Screw



Self-Tapping Rescue Screws












IRIX-A™ Lumbar Integrated Fusion System Surgical Technique

This document is intended exclusively for experts in the field, particularly physicians, and is not intended for laypersons. Information on the products and procedures contained in this document is general in nature and does not represent medical advice or recommen-dations. As with any technical guide, this information does not constitute any diagnostic or therapeutic statement with regard to a given medical case. An evaluation, examination, and advising of the patient are absolutely necessary for the physician to determine the specific requirements of the patient, and any appropriate adjustments needed, and the foregoing are not to be replaced by this document in whole or in part. Information contained in this document was gathered and compiled by experts in the field and X-spine employees to the best of their knowledge. Care was taken to ensure the information contained herein is accurate and understandable. X-spine does not assume any liability, however, for the accuracy and/or completeness of the quality of the information, and X-spine is not liable for any losses whatsoever of any kind or any nature that may be caused by the use and/or reliance of said information.

Step 1: Patient Positioning

The patient is placed in the supine position for a direct approach to the anterior lumbar spine at the midline for the vertebrae to be fused.

OR SETUP AND PREPARATION:

Step 2: Exposure and Distraction

Use a straight metal instrument to confirm the appropriate operative level is located through the use of radiography. This will ensure direct access into the disc space. Create an incision and retract using traditional methods for an anterior approach to allow for adequate exposure and visualization of the desired operative levels.

CAUTION: Anterior exposure of the lumbar spine is anatomically challenging, particularly above L4-5. The anterior approach and exposure should only be performed by an expert surgeon who is capable of urgently recognizing and repairing vascular and intra-abdominal complications. Complications of the anterior approach may also include sexual dysfunction, including retrograde ejaculation. Breach of iliac vessels during anterior spinal surgery, including unrecognized breach, has resulted in patient death. Reoperation and scarring of the prevertebral structures significantly increases complication risk.

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Step 3: Discectomy and Endplate Preparation

The vertebral disc should be excised using a standard technique.

The Rasp instrument should be used to carefully decorticate the endplate surfaces.

CAUTION: Care should be taken to avoid plunging disc prep instrumentation into surrounding neurological structures.

Step 4: Implant Sizing

Use the Trial instruments to determine the footprint, height, and lordosis of the Implant to be used; a secure fit is desirable. Great care should be taken to maintain the anatomy and protect the neurological structure.

It is recommended that distraction be used during trialing to ensure secure implantation. Implants which are undersized carry an increased risk of pseudarthrosis and spacer expulsion.

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Note: Trials are the same height as PEEK portion of the implant. Note: The fork in the Mallet may be used to dislodge the Trial from the disc space by slapping it against the flange on the Trial.

Step 6: Implant Loading

Select the appropriate Inserter Tip for the determined implant footprint.

Rotate the Inserter’s locking nut clockwise and/or counter-clockwise to align the laser marked loading zone. Place the selected Inserter Tip onto the distal end of the instrument. Once fully seated, move the collar over the tip and rotate clockwise to tighten.

Step 5: Implant Preparation

The appropriate sized sterile implant should be selected and packed with bone graft material.

Note: There is a Graft Packing Block and Graft Tamp available for use. Additionally, the Graft Packing Block has been designed so it can be used when the implant is attached to the Inserter.

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While holding the implant against the Inserter Tip, turn the Inserter’s locking nut clockwise to engage the Inserter Tip with the instrument.

Once the implant is secured to the Inserter, tighten the side thumb screw (on the side of the Inserter just below the tightening nut).

CAUTION: Failure to adequately tighten the Inserter’s locking nut and confirm the interface may result in loosening or release of the implant, resulting in injury.

CAUTION: Failure to adequately tighten the threaded collar may result in loosening or release of the Inserter Tip and/or implant, resulting in injury.

Step 8: Screw Hole Preparation and Screw Insertion

Screw Hole Preparation Place the Universal Awl into the Awl Guide Tube. Then place the Guide Tube into one of the screw holes in the Implant. Use the Universal Awl through the Guide Tube to break the cortex.

CAUTION: Use care to make sure the implant does not migrate posteriorly during screw preparation or placement. Posterior displacement of the implant can result in neurological injury. It is recommended to insert a screw in the first prepared hole before preparing another hole. Installing fewer than three screws will significantly reduce the implant fixation and increase the risk of implant failure.

Step 7: Implant Insertion

Under fluoroscopy, the implant should be gently impacted into the intervertebral space at the midline. The implant should be recessed into the disc space approximately 2mm. Radiographic imaging of the Integrated Titanium Ring and titanium plasma coated portions of the implant can be used to determine implant position.

CAUTION: The implant should be impacted in place with great care as over impaction of the implant or positioning the implant too far posteriorly can result in neurological injury. To avoid posterior displacement, take care in adjusting the implant or instrumentation.

Once the implant is positioned, disengage the inserter by first loosening the side thumbscrew and then turning the locking nut counter-clockwise. Remove the inserter from the body. Care should be taken to avoid neurological structures during inserter removal.

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Screw InsertionPlace the desired length screw on the Screwdriver and insert the screw. Do not over tighten. A click may be heard as the screw passes the locking arm on the faceplate. This indicates the screw is near the final tightened position.

CAUTION: Over-angulation of the screw beyond 3 degrees in any direction may result in failure of the screw to engage the implant and/or locking arm.

Step 9: Final Imaging

Final radiographic imaging of the implant and screws should be performed to confirm placement.

Visual confirmation of the locking arm over the screw and the screw’s full seating in the faceplate should be performed.

CAUTION: Failure to confirm that the locking arm is in front of the screw may result in early or late screw loosening.

Screws should be placed immediately following screw hole preparation. Preparing multiple screw sites before inserting a screw is not recommended. Installing screws one at a time ensures minimal implant movement during screw insertion.

Install the remaining two screws following the aforementioned steps. It is recommended inserting two screws into the superior vertebral body, then one screw into the inferior vertebral body. The Irix-A Lumbar Integrated Fusion System requires three screws to be installed.

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Alignment of Removal Instrument and Retaining Hook

Removal Instrument rotated to move the Retaining Hook

**System Removal or Revision: Should it become necessary to remove or revise the Irix-A™ Lumbar Integrated Fusion System implants, the following steps should be followed:

Step 1: Screw Removal

After the screw has been properly inserted, the screw may then be removed from its position using the Screw Removal Instrument. The removal instrument has an outer sleeve with an oval distal tip that, when properly aligned with the locking arm using the laser marking, can be rotated 180° to push the locking arm over and out of the screw path. This will allow the surgeon to back the screw out past the retaining hook by rotating the inner hex shaft counter-clockwise.

**Note: if resistance is felt while trying to rotate the outer sleeve or during the initial counter-clockwise turning of the inner sleeve, the screw may need to be advanced prior to removal. Advance the screw by rotating the inner hex shaft ¼ - ½ turns clockwise to ensure that the screw head is seated beyond the lip of the locking arm prior to screw removal.

Step 2: Implant Removal

After the screws have been removed, the Implant may be removed by re-engaging the implant with the appropriate Inserter Tip loaded onto the Implant Inserter and following (Step 6) – Implant Loading. The forked end of the Mallet may be used as a slap hammer to help persuade the implant to back out of the intervertebral disc space.

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Alignment of Angled Screw Removal Sleeve and Retaining Hook

Angled Screw Removal Sleeve rotated to move the Retaining Hook

Step 1: Alternate – Screw Removal

After the screw has been properly inserted, the screw may then be removed from its position using the Angled Screw Removal Sleeve(red handle) and the Universal Joint Screwdriver or Straight Screwdriver. The Angled Screw Removal Sleeve has an oval distal tip that, when properly aligned with the locking arm, can be rotated 90° to push the locking arm over and out of the screw path. This will allow the surgeon to back the screw out past the retaining hook by turning the screwdriver counter-clockwise.

**Note: If resistance is felt while trying to rotate the Angled Screw Removal Sleeve or during the initial counter-clockwise turning of the screwdriver, the screw may need to be better seated prior to removal. Advance the screw by rotating the screwdriver ¼ - ½ turns clockwise to ensure that the screw head is seated beyond the lip of the locking arm prior to screw removal.

Step 2: Alternate – Implant Removal

After the screws have been removed, the Implant may be removed by re-engaging the implant with the appropriate Inserter Tip loaded onto the Implant Inserter and following (Step 6) – Implant Loading. The forked end of the Mallet may be used as a slap hammer to help persuade the implant to back out of the intervertebral disc space.

IRIX-ATM INSTRUMENTS

T080-0080 Inline Screw Removal Instrument

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T080-0060 Straight Tap

T080-0070 Straight Screwdriver

T080-0066 Universal Joint Tap

T080-0076 Universal Joint Screwdriver

T080-0055 Universal Joint Awl

T080-0030 Mallet/Extractor

T080-0020 Graft Packer

T080-0025 Graft Packing Block

T080-0085 Angled Screw Removal Sleeve

T080-0085 Awl Guide

N60000473 In-Line Handle

N60000472 Ratcheting T-Handle

T080

-005

6 S

elf-C

ente

ring

Aw

l

T080

-004

2 Im

plan

t Ins

erte

r

Implant Inserter Tips T080-3326 (33 x 26mm)T080-3828 (38 x 28mm)T080-4230 (42 x 30mm)

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T080-0100-1 12mm Osteotome

T080-0100-12(4mm), T080-0100-13(6mm) Straight Up Angle Cup Curette

T080-0100-15 6mm Right Angle Cup Curette

T080-0100-2(20mm), T080-0100-3(25mm) Elevator

T080-0100-14 6mm Left Angle Cup Curette

T080-0100-16 4mm Ring Curette, T080-0100-17 8mm Ring Curette

T080-0100-18 4mm x 11mm Teardrop Curette

T080-0100-19 20mm X 8mm Box Curette

T080-0100-20 8mm Up Angled Double Sided Rasp

T080-0100-7 8mm Bone Rongeur

T080-0100-9(4mm), T080-0100-10(6mm), T080-0100-11(8mm) Anterior Kerrison Rongeur

T080-0100-4(4mm), T080-0100-5(6mm), T080-0100-6(8mm) Pituitary Rongeur

Implant Inserter Tips T080-3326 (33 x 26mm)T080-3828 (38 x 28mm)T080-4230 (42 x 30mm)

T080-0100-8 Scalpel Handle

33 x 26mm8° Lordotic T080-332611-08TR(11mm) to -332619-08TR(19mm)12° Lordotic T080-332611-12TR(11mm) to -332619-12TR(19mm)



Trial

WARNING: In the USA, this product has labeling limitations. See package insert for complete information.

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.

X-spineSM the X-spine logoSM and Irix-A™ are trademarks or servicemarks of X-spine Systems, Inc.

Products Patented and Patents Pending

All products are not currently available in all markets.

© 2015 X-spine Systems, Inc., All rights reserved.

F-1000.50 Rev. C

X-spine Systems, Inc.452 Alexandersville Rd., Miamisburg, OH 45342

Phone: 800-903-0640 • Direct: 937-847-8400 • Fax: 937-847-8410www.x-spine.com

X-spine Surgical Technique

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