The Synex™ II implant is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synex II device is intended to be used with Synthes supplemental internal fixation systems, e.g., TSLP, Pangea and USS.

The Synex II device is designed to provide anterior spinal column support, even in the absence of fusion, for a prolonged period.

Device Description

The Synex II Spacer is a height expanding vertebral body replacement device consisting of a hollow central body and two endplates. The cylindrical body is comprised of two telescoping end pieces and a locking ring. The walls of the hollow cylindrical body have a plurality of holes intended for the placement of grafting materials to help achieve a solid fusion. Endplates are available in three footprint sizes. Each endplate is angled, has a plurality of holes and is designed with pyramidal teeth and small spikes to grip the adjacent vertebra.

AI/ML Overview

The SYNEX™ II Spacer is a spinal intervertebral body fixation device. The manufacturer conducted mechanical testing to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document states that "Mechanical testing in accordance with the 'Guidance for Spinal System 510(k)s', issued May 3, 2004, was presented." However, the specific acceptance criteria (e.g., minimum load to failure, fatigue life) from this guidance document and the detailed results of the SYNEX™ II Spacer's performance against these criteria are not explicitly provided in the given text.

Therefore, the table below indicates that the specific criteria and results are not reported within this summary. To fully populate this table, one would need access to the detailed mechanical testing report submitted to the FDA, which is beyond the scope of the provided excerpts.

Acceptance Criteria (from "Guidance for Spinal System 510(k)s")	Reported Device Performance
Not explicitly reported in this 510(k) summary	Not explicitly reported in this 510(k) summary
(e.g., Axial Compression Strength)	(e.g., Device met or exceeded [X] N)
(e.g., Axial Compression Fatigue)	(e.g., Device survived [Y] cycles at [Z] N)
(etc.)	(etc.)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified in the provided text. Mechanical testing typically involves a certain number of samples for each test type (e.g., n=3 or n=6 per condition), but the exact number is not reported here.
Data Provenance: The testing was conducted by the manufacturer, Synthes Spine Co. L.P. The location of the testing facility is not explicitly stated, but it would have been an in-house lab or a contracted testing facility. The data is based on scientific/engineering testing of physical samples, not human clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This question is not applicable as the study involved mechanical testing of the device, not a human reader study or clinical trial requiring expert ground truth establishment for a diagnostic outcome. The "ground truth" for mechanical testing is derived from established engineering principles and measurements against validated testing standards.

4. Adjudication Method for the Test Set:

This question is not applicable for mechanical testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for radiology reads, to resolve discrepancies among expert readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. This device is an implantable medical device undergoing mechanical performance testing, not an AI-enabled diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance evaluation was not done. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this study was established through adherence to standardized mechanical testing protocols and specifications outlined in the "Guidance for Spinal System 510(k)s" issued May 3, 2004. This ground truth is based on quantitative measurements (e.g., force, displacement, cycles) and material properties that simulate the physiological environment.

8. The Sample Size for the Training Set:

This question is not applicable. Mechanical testing does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as #8.

Summary

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K061891 pg 1 of 2

5.0 510(K) Summary

AUG 1 8 2006

Name of Firm	Synthes Spine Co. L.P.1302 Wrights Lane EastWest Chester, PA 19380
510(k) Contact	Bonnie J. Smith
Device Trade Name	Synex ™ II
Common/Classification Name	Spinal intervertebral body fixation device
Panel/Product Code and Classification	Panel Code 87Product Code MQP21 CFR 888.3060: Class II
Predicate Device	K003836 - Synex ™ Spacer
Device Description	The Synex II Spacer is a height expanding vertebralbody replacement device consisting of a hollow centralbody and two endplates. The cylindrical body iscomprised of two telescoping end pieces and a lockingring. The walls of the hollow cylindrical body have aplurality of holes intended for the placement of graftingmaterials to help achieve a solid fusion. Endplates areavailable in three footprint sizes. Each endplate isangled, has a plurality of holes and is designed withpyramidal teeth and small spikes to grip the adjacentvertebra.
Indications for Use	The Synex II Spacer is a vertebral body replacementdevice intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstablevertebral body due to tumor or trauma (i.e., fracture).The Synex II device is intended to be used withSynthes supplemental internal fixation systems, e.g.,TSLP, Pangea, or USS.The Synex II Spacer is designed to provide anteriorspinal column support even in the absence of fusion fora prolonged period of time.

CONFIDENTIAL

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K044891 pg 2 of 2

5.0 510(K) Summary (continued)

Substantial Equivalence	The Synthes Synex II Spacer implants are similar tothe components of previously cleared spinal systems,Synthes Synex, K003836, and DePuy Stackable CageSystem, K001340. The supplement fixation devicesfor use with the Synex II are cleared for use inpatients with tumor, trauma or fractures.
Material	All components of the Synex II Spacer aremanufactured from titanium alloy, Ti6A17Nb (ASTMF 1295).
Performance Data	Mechanical testing in accordance with the "Guidancefor Spinal System 510(k)s", issued May 3, 2004, waspresented.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2006

Synthes Spine Co. L.P. % Ms. Bonnie J. Smith Regulatory Affairs Project Manager 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K061891

Trade/Device Name: SYNEX™ II Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Vertebral Body Replacement Device Regulatory Class: Class II Product Code: MQP Dated: June 30, 2006 Received: July 3, 2006

Dear Ms. Smith:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Bonnie J. Smith

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276- 0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

510(k) Number: K061891

Device Name: SYNEX™ II Spacer

The Synex II device is designed to provide anterior spinal column support, even in the absence of fusion, for a prolonged period.

Prescription Use X (21 CFR 801.109 Subpart D) OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chabara buchens for MXM
Division Sign-Off

Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.