The Stryker Spine AVS® AS PEEK Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AVS® AS PEEK Spacers are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.

The AVS® AS PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Device Description

The Stryker Spine AVS® AS PEEK Spacer is a hollow, ring-shaped PEEK Optima® LT1 cage (per ASTM F2026) with three Tantalum marker pins (per ASTM F560). It is intended for use as an interbody fusion device of the cervical spine and is offered in a variety of lengths, heights, and lordotic angles to adapt to varying patient anatomies. The hollow, ring-shaped implant has serrations on the top and bottom for fixation. The hollow space of the implant is intended to hold bone graft material for fusion purposes.

AI/ML Overview

This document is a 510(k) summary for the Stryker Spine AVS® AS PEEK Spacer. It does not describe an AI medical device or a study involving acceptance criteria and device performance in the context of AI. Instead, it concerns the expansion of indications for use for an intervertebral body fusion device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI device. This document pertains to a physical medical implant and its expanded use with different types of bone graft.

Summary

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

November 19, 2014

Stryker Spine Garry T. Haveck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K142251

Trade/Device Name: AVS® AS PEEK Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: August 13, 2014 Received: August 15, 2014

Dear Dr. Hayeck:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Garry T. Hayeck, Ph.D.

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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K142251

Device Name AVS® AS PEEK Spacer

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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510(k) Summary: Expanded Indications for Use, Stryker Spine AVS® AS PEEK Spacer
Submitter	Stryker Spine2 Pearl CourtAllendale, NJ 07401
Contact Person	Garry T. Hayeck, Ph.D.Senior Regulatory Affairs SpecialistPhone: 201-760-8043Fax: 201-962-4043E-mail: garry.hayeck@stryker.com
Date Prepared	October 22, 2014
Trade Name	AVS® AS PEEK Spacer
Common Name	Intervertebral fusion device with bone graft, cervical
Proposed Class	Class II
Additional Classification
• Codification	21 CFR § 888.3080
• Name	Intervertebral body fusion device
Product Codes	ODP
Predicate Devices	The AVS® AS PEEK Spacer was shown to be substantially equivalent tothe devices listed below:Primary Predicate Device:Stryker Spine, AVS® AS PEEK SPACER, K120486Additional Predicate Device:Medtronic Sofamor Danek, ANATOMIC PEEK CERVICAL FUSIONSYSTEM, K130177
Device Description	The Stryker Spine AVS® AS PEEK Spacer is a hollow, ring-shaped PEEKOptima® LT1 cage (per ASTM F2026) with three Tantalum marker pins(per ASTM F560). It is intended for use as an interbody fusion device ofthe cervical spine and is offered in a variety of lengths, heights, andlordotic angles to adapt to varying patient anatomies. The hollow,ring-shaped implant has serrations on the top and bottom for fixation.The hollow space of the implant is intended to hold bone graftmaterial for fusion purposes.
Indications for Use	The Stryker Spine AVS® AS PEEK Spacers are indicated for use incervical interbody fusion procedures in skeletally mature patients withdegenerative disc disease (DDD) at one level from the C2-C3 disc tothe C7-T1 disc. DDD is defined as neck pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The AVS® AS PEEK Spacers are to be used with autogenousbone graft and/or allogenic bone graft comprised of cancellousand/or corticocancellous bone graft.
	open, anterior approach.
	The AVS® AS PEEK Spacers are intended to be used with supplementalfixation systems that have been cleared for use in the cervical spine.This cervical device is to be used in patients who have had six weeksof non-operative treatment.
Summary ofTechnologicalCharacteristics	The subject AVS® AS PEEK Spacer and the predicates share similardesign features:• Graft windows for packing autogenous or allogenic bone• Serrations on the superior and inferior surfaces• Comparable heights, widths, depths, and lordotic angles
	The purpose of this 510(k) submission is to seek clearance for use ofallogenic bone graft comprised of cancellous and/orcorticocancellous bone graft as an alternative to autogenous bonegraft. No changes have been made to the actual implants.
Summary of thePerformance Data	Published clinical data for the cervical interbody fusion devices similarto the AVS® AS PEEK Spacer was provided in support of thisapplication. The published clinical outcomes demonstrated that theuse of allogenic bone graft comprised of cancellous and/orcorticocancellous bone graft in anterior cervical interbody fusionprocedures to treat patients diagnosed with cervical disc disease asdefined above does not adversely affect performance of the systemand does not represent a new worst case scenario. No changes weremade to the existing devices, nor were any new components addedto the system. Therefore, no additional testing was required orperformed.
Conclusion	The design features, materials used, manufacturing, and sterilizationmethods are identical to the previously cleared AVS® AS PEEK Spacercomponents with the exception of broadening the indications toinclude the use of allogenic bone graft comprised of cancellousand/or corticocancellous bone graft as an alternative graft material.The data presented in this submission demonstrates that the safetyand effectiveness of the AVS® AS PEEK Spacers when used withallogenic bone graft comprised of cancellous and/orcorticocancellous bone graft is substantially equivalent to the safetyand effectiveness of the predicate systems when used with autograft.

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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.