The SYNFIX Lateral is a stand-alone lateral lumbar interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. The interior of the SYNFIX Lateral spacer component should be packed with autogenous bone graft (i.e. autograft); all four screws must be used when implanting this device.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Device Description

The DePuy Synthes SYNFIX Lateral is a combination radiolucent and radiopaque intervertebral body fusion device. Four screws are inserted through the laterally located plate into the adjacent vertebral bodies. The screws lock securely to the plate using a conical thread locking mechanism.
The DePuy Synthes SYNFIX Lateral is available in various heights and geometries to suit individual pathology and anatomical conditions.

AI/ML Overview

The provided text describes a 510(k) summary for the DePuy Synthes SYNFIX Lateral, an intervertebral body fusion device. It details non-clinical performance data but explicitly states that clinical data and conclusions were not needed for this device.

Therefore, the following information cannot be provided as it pertains to clinical studies, human performance, or AI algorithms, which are not relevant to this submission.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not specified as this is a non-clinical submission based on substantial equivalence to predicate devices and bench testing.
Reported Device Performance: The primary reported performance conclusion is that the device is "substantially equivalent in performance to predicate devices" based on bench testing. Specific numerical performance values against acceptance criteria are not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable as clinical data was not needed. Bench testing was performed but sample sizes for those tests are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as clinical data was not needed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as clinical data was not needed.

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

Not applicable. This device is a physical implant, not an AI or imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical implant, not an AI or imaging diagnostic tool.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable as clinical data was not needed. For non-clinical bench testing, the ground truth would be established by physical measurements and engineering standards.

8. The sample size for the training set

Not applicable as clinical data or AI algorithms requiring training sets were not used.

9. How the ground truth for the training set was established

Not applicable as clinical data or AI algorithms requiring training sets were not used.

Summary of Device Acceptance:

The DePuy Synthes SYNFIX Lateral device's acceptance was based on non-clinical performance and substantial equivalence to previously cleared predicate devices.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria was a series of bench tests and cadaveric studies.

Bench Testing: Conducted in accordance with FDA Guidances and ASTM standards (ASTM F2077-11, ASTM F2267-04, ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119). The tests included:
- Static Axial Compression
- Dynamic Axial Compression
- Static Compression Shear
- Dynamic Compression Shear
- Expulsion
- Subsidence
Cadaveric Studies: Conducted to evaluate performance in flexion/extension and lateral bending.
Safety and Compatibility: MR environment safety and compatibility were established according to FDA Guidance and ASTM standards.

Conclusion from Studies:

The conclusions drawn from these tests demonstrated that the DePuy Synthes SYNFIX Lateral is substantially equivalent in performance to predicate devices. Clinical data and conclusions were explicitly stated as not needed for this device submission.

Summary

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K131276 Page 1 of 2

510(k) Summary

510(k) Summary -SYNFIX Lateral
Name of Firm:	DePuy Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
510(k)Contact:	Monika McDole-RussellRegulatory Affairs SpecialistTelephone: 610-719-5448Facsimile: 484-356-9682Email: mcdole-russell.monika@synthes.com
Date Prepared:	January 3, 2014
TradeName(s):	DePuy Synthes SYNFIX Lateral
Classification:	21 CFR 888.3080 - Intervertebral Body Fusion DeviceClass II (special controls)Orthopaedic and Rehabilitation Devices Panel (87)Product Code OVD (Intervertebral Fusion Device with IntegratedFixation, Lumbar)
Predicates:	Synthes SynFix-LR Spacer (K072253)Zimmer Spine BAK Vista Interbody Fusion Cage (P950002 S014)Medtronic SOVEREIGN (K121982)Globus Medical InterContinental (K103382)DePuy Synthes Falcon Spacer (K123180)
DeviceDescription(s):	The DePuy Synthes SYNFIX Lateral is a combination radiolucent andradiopaque intervertebral body fusion device. Four screws are insertedthrough the laterally located plate into the adjacent vertebral bodies. Thescrews lock securely to the plate using a conical thread lockingmechanism.The DePuy Synthes SYNFIX Lateral is available in various heights andgeometries to suit individual pathology and anatomical conditions.
Intended Use/Indications forUse:	The SYNFIX Lateral is a stand-alone lateral lumbar interbody fusiondevice indicated for use in patients with degenerative disc disease (DDD)at one or two contiguous levels from L2 to L5. The interior of theSYNFIX Lateral spacer component should be packed with autogenousbone graft (i.e. autograft); all four screws must be used when implantingthis device.DDD is defined as back pain of discogenic origin with degeneration of thedisc confirmed by history and radiographic studies. These patients shouldbe skeletally mature and have had six months of non-operative treatment.
510(k) Summary –SYNFIX Lateral
Comparison ofthe device topredicatedevice(s):	The DePuy Synthes SYNFIX Lateral Spacer is substantially equivalent tothe predicates in design, function, performance, material, and intendeduse.
PerformanceData(Non-Clinicaland/orClinical):	Non-Clinical Performance and Conclusions:DePuy Synthes conducted the following bench testing (as recommendedwithin FDA Guidances and in accordance with ASTM F2077-11 andASTM F2267-04): Static Axial Compression; Dynamic AxialCompression; Static Compression Shear; Dynamic Compression Shear;Expulsion; Subsidence. Cadaveric studies were conducted to evaluateperformance in flexion/extension and lateral bending.The conclusions drawn from testing demonstrate that the DePuy SynthesSYNFIX Lateral is substantially equivalent in performance to predicatedevices.In addition, the safety and compatibility of SYNFIX Lateral implants inan MR environment was established (as recommended with FDAGuidance and in accordance with the ASTM F2052, ASTM F2213,ASTM F2182 and ASTM F2119).Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters and is evenly spaced around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 6, 2014

Depuy Synthes Spine Ms. Monika McDole-Russell Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K131276

Trade/Device Name: DePuy Synthes SYNFIX Lateral Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: November 26. 2013 Received: November 27, 2013

Dear Ms. McDole-Russell:

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. 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 801); medical device reporting (reporting of medical

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Page 2 - Ms. Monika McDole-Russell

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note. the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Lori A. Wiggins

for Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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K131276 Page 1 of 1

Indications for Use Statement

K_ 131276 510(k) Number(s): (if known)

Device Name: DePuy Synthes SYNFIX Lateral

Anton EDmitriev, PhD Division of Orthopedio Devices

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.