The Stryker Spine AVS® AL and AVS® ALign PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® AL and AVS® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach.

The AVS® AL and AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

The AVS® TL Peek Spacers are to be implanted via posterior approach.

The AVS® TL PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

The AVS® Navigator PEEK Spacers are to be implanted via a posterior or posterolateral approach.

The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® ARIA PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

The AVS® ARIA PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The AccuLIF TL and PL Cage are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

The Stryker Spine AVS® Anchor-L is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach.

The AVS® Anchor-L Lumbar Cage system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the AVS® Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by AVS® Anchor-L Fixation Screws and Locking Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be used anytime the device is used with any number of screws.

The Stryker Spine Aero™-AL is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

The Aero™-AL Lumbar Cage System is to be implanted via an anterior approach.

The Aero™-AL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems) in addition to the included fixation anchors.

Device Description

AVS® AL and AVS® ALign PEEK Spacers
The AVS® AL (Anterior Large) and AVS® ALign PEEK Spacers are intended for use as interbody fusion devices. They are offered in a variety of lengths, heights and lordotic angles. The hollow, ring shaped implant has serrations on the top and bottom for fixation. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization.
AVS® PL and AVS® UniLIF PEEK Spacers
The AVS® Partial Lumbar (PL) PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended for use as an aid in spinal fixation. This hollow, rectangular implant is offered in a variety of lengths, heights and lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior surfaces of the implant designed to help with fixation, an ergonomically shaped anterior edge, and a flat posterior edge. Radiopaque markers have been embedded within the implant to help allow for visualization in radiographic images. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization.
AVS® TL PEEK Spacer
The AVS® TL PEEK Spacer is intended for use as an aid in spinal fixation. It is offered in both parallel and wedge shapes. The hollow implant has serrations on the top and bottom which are designed to help with fixation. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization.
AVS® Navigator PEEK Spacer
The AVS® Navigator PEEK Spacer is intended for use as an interbody fusion device. It is offered in a variety of lengths, heights and lordotic angles. The hollow implant has serrations on the top and bottom for fixation. Radiopaque markers have been embedded within the implant to help allow for visualization in radiographic images. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization.
AVS® ARIA PEEK Spacer
The AVS® ARIA PEEK Spacer is intended for use as an interbody fusion device. It is offered in a variety of lengths, heights and lordotic angles. The hollow, oblong-shaped implant has serrations on the top and bottom for fixation. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization.
AccuLIF TL and PL Cage
The AccuLIF TL and PL Expandable Lumbar Interbody Cages are crescent and rectangular-shaped titanium implants. These implants are intended for use as interbody fusion devices and are offered in a variety of lengths, footprints, and lordotic angles designed to adapt to different patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants automatically lock at 1mm increments during expansion. The implants have serrations on the superior and inferior surfaces designed for multidirectional fixation and increased surface area for osteointegration, ergonomically shaped anterior edges to facilitate cage insertion with preservation of endplates and flat posterior edges. The cages have a central opening spanning endplate to endplate for graft containment and to permit fusion through the device. The cages are manufactured from implant grade titanium alloy (Ti-6Al-4V), stainless steel (316 LVM), and silicone rubber (MED-4870).
AVS® Anchor-L Spacer
The AVS® Anchor-L Lumbar Cage System consists of a hollow, rectangular-shaped PEEK OPTIMA LT1 cage, titanium alloy (Ti-6Al-4V) bone screws, and a titanium alloy (Ti-6Al-4V) locking plate. Tantalum markers are included for visualization. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to adapt to varying patient anatomies. The AVS® Anchor-L cage consists of one closed pocket for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used exclusively with the internal supplemental fixation provided.
Aero™-AL Lumbar Cage System
The Aero™-AL Cage is a hollow, box-shaped PEEK OPTIMA LT1 cage surrounded by a titanium alloy (Ti-6Al-4V) jacket. The PEEK cage portion consists of three closed pockets for graft containment and has serrations on the superior and inferior surfaces of the cage. The cage is designed to be used with the integrated fixation provided (Aero™-AL Fixation Anchors) in addition to supplemental fixation systems cleared for use in the lumbosacral spine. The Aero™-AL Fixation Anchors are constructed from titanium alloy (Ti-6Al-4V) and feature rails that mate with dovetail channels located within the Aero™-AL PEEK cage. Once fully seated into the channels, the anchors are designed to lock into the titanium jacket.

AI/ML Overview

This document is a 510(k) premarket notification for several intervertebral body fusion devices from Stryker Corporation. The core purpose of this submission is to expand the indications for use of these devices to include the use of allogenic bone graft (comprised of cancellous and/or corticocancellous bone graft) as an adjunct to fusion, in addition to the previously cleared autograft.

The document does not describe a study that proves the device meets acceptance criteria related to a novel AI/ML algorithm or its performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices for an expanded indication of use, specifically concerning the type of bone graft.

Therefore, many of the requested categories for AI/ML device studies will not be applicable. I will address the relevant information provided in the document.

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

Since this is not an AI/ML device performance study, there are no specific numerical acceptance criteria or reported device performance metrics in the way one would see for an AI/ML diagnostic or predictive tool. The "performance" assessment here is conceptual, centered on demonstrating that the change in bone graft type does not adversely affect safety and effectiveness compared to the predicate devices.

Acceptance Criteria (Implicit for Substantial Equivalence for Expanded Indication)	Reported Device Performance (Summary of Evidence)
Expanded indication for allogenic bone graft does not adversely affect device performance.	Published clinical data for lumbar interbody fusion devices similar to the Stryker Spine devices was provided. This clinical data demonstrated that the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion in patients with degenerative disc disease (DDD) does not adversely affect performance of the system and does not represent a new worst-case scenario. The document explicitly states: "No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed." The conclusion is that the devices with the broadened indications are substantially equivalent to the predicate systems.
The device maintains its safety and effectiveness with the expanded indication.	Same as above. The safety and effectiveness are established through substantial equivalence to predicate devices and the reasoning that the change in bone graft type, supported by similar clinical data for other devices, does not introduce new risks or alter existing performance.

Acceptance Criteria (Implicit for Substantial Equivalence for Expanded Indication)

Reported Device Performance (Summary of Evidence)

Expanded indication for allogenic bone graft does not adversely affect device performance.

Published clinical data for lumbar interbody fusion devices similar to the Stryker Spine devices was provided. This clinical data demonstrated that the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion in patients with degenerative disc disease (DDD) does not adversely affect performance of the system and does not represent a new worst-case scenario. The document explicitly states: "No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed." The conclusion is that the devices with the broadened indications are substantially equivalent to the predicate systems.

The device maintains its safety and effectiveness with the expanded indication.

Same as above. The safety and effectiveness are established through substantial equivalence to predicate devices and the reasoning that the change in bone graft type, supported by similar clinical data for other devices, does not introduce new risks or alter existing performance.

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

Not applicable. No new test set for device performance was generated or utilized for this submission as "no additional testing was required or performed." The submission relies on "published clinical data for lumbar interbody fusion devices similar to the Stryker Spine lumbar intervertebral body fusion devices." The provenance of this published data is not specified (e.g., country of origin, retrospective/prospective).

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. No new test set requiring expert ground truth establishment was conducted for this submission. The "ground truth" for the expanded indication is based on existing "published clinical data" for similar devices, which would have implicitly relied on clinical diagnoses and outcome assessments by medical professionals at the time of publication.

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

Not applicable. No new test set requiring adjudication was conducted.

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 submission is for an intervertebral body fusion device (a physical implant), not an AI/ML algorithm. Therefore, no MRMC study, AI assistance, or effect size calculation for human readers is relevant.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" in this context refers to the clinical evidence supporting the use of allogenic bone graft in lumbar interbody fusion devices. This is based on published clinical outcomes data from studies of similar lumbar interbody fusion devices, demonstrating that the use of allogenic bone graft did not adversely affect performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable. This is not an AI/ML algorithm that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

January 26, 2015

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

Re: K143163

Trade/Device Name: AVS® AL and AVS® ALign PEEK Spacers, AVS® PL and AVS® UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, and Aero™-AL Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: October 31, 2014 Received: November 3, 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

{1}------------------------------------------------

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

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 of medical 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 vou 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 yours,

Lori A. Wiggins -S

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

Enclosure

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510(k) Number (if known) K143163

Device Name AVS® AL and ALign PEEK Spacers

Indications for Use (Describe)

The Stryker Spine AVS® AL and AVS® ALign PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

The AVS® AL and AVS® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach.

The AVS® AL and AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{3}------------------------------------------------

510(k) Number (if known) K143163

Device Name AVS® PL and UniLIF PEEK Spacers

Indications for Use (Describe)

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

{4}------------------------------------------------

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{5}------------------------------------------------

510(k) Number (if known) K143163

Device Name AVS® TL PEEK Spacer

Indications for Use (Describe)

The AVS® TL Peek Spacers are to be implanted via posterior approach.

The AVS® TL PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{6}------------------------------------------------

510(k) Number (if known) K143163

Device Name AVS® Navigator PEEK Spacer

Indications for Use (Describe)

The AVS® Navigator PEEK Spacers are to be implanted via a posterolateral approach.

The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

{7}------------------------------------------------

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{8}------------------------------------------------

510(k) Number (if known) K143163

Device Name AVS® ARIA PEEK Spacer

Indications for Use (Describe)

The Stryker Spine AVS® ARIA PEEK Spacers are intervertebral body fusion devices indicated for use with autograff and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

The AVS® ARIA PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{9}------------------------------------------------

510(k) Number (if known) K143163

Device Name AccuLIF TL and PL Cage

Indications for Use (Describe)

The AccuLIF TL and PL Cage are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{10}------------------------------------------------

510(k) Number (if known) K143163

Device Name AVS® Anchor-L Spacer

Indications for Use (Describe)

The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach.

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

{11}------------------------------------------------

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{12}------------------------------------------------

510(k) Number (if known) K143163

Device Name Aero™-AL Lumbar Cage System

Indications for Use (Describe)

The Aero™-AL Lumbar Cage System is to be implanted via an anterior approach.

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

ال Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

{13}------------------------------------------------

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{14}------------------------------------------------

510(k) Summary: Expanded Indications for Use
Stryker Spine Lumbar Intervertebral Body Fusion Devices
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	January 22, 2015
Trade Name	1. AVS® AL and AVS® ALign PEEK Spacers2. AVS® PL and AVS® UniLIF PEEK Spacers3. AVS® TL PEEK Spacer4. AVS® Navigator PEEK Spacer5. AVS® ARIA PEEK Spacer6. AccuLIF TL and PL Cage7. AVS® Anchor-L Spacer8. AeroTM-AL Lumbar Cage System
Common Name	1. AVS® AL and AVS® ALign PEEK SpacersIntervertebral fusion device with bone graft, lumbar2. AVS® PL and AVS® UniLIF PEEK SpacersIntervertebral fusion device with bone graft, lumbar3. AVS® TL PEEK SpacerIntervertebral fusion device with bone graft, lumbar4. AVS® Navigator PEEK SpacerIntervertebral fusion device with bone graft, lumbar5. AVS® ARIA PEEK SpacerIntervertebral fusion device with bone graft, lumbar6. AccuLIF TL and PL CageIntervertebral fusion device with bone graft, lumbar7. AVS® Anchor-L SpacerIntervertebral fusion device with bone graft, lumbar8. AeroTM-AL Lumbar Cage SystemIntervertebral fusion device with integrated fixation, lumbar
Proposed Class	1. AVS® AL and AVS® ALign PEEK SpacersClass II2. AVS® PL and AVS® UniLIF PEEK SpacersClass II3. AVS® TL PEEK SpacerClass II4. AVS® Navigator PEEK SpacerClass II
		5. AVS® ARIA PEEK Spacer
		Class II
		6. AccuLIF TL and PL Cage
		Class II
		7. AVS® Anchor-L Spacer
		Class II
		8. Aero™-AL Lumbar Cage System
		Class II
Classification Name,Codification	1.	AVS® AL and AVS® ALign PEEK SpacersIntervertebral body fusion device , 21 CFR § 888.3080
	2.	AVS® PL and AVS® UniLIF PEEK SpacersIntervertebral body fusion device , 21 CFR § 888.3080
	3.	AVS® TL PEEK SpacerIntervertebral body fusion device , 21 CFR § 888.3080
	4.	AVS® Navigator PEEK SpacerIntervertebral body fusion device , 21 CFR § 888.3080
	5.	AVS® ARIA PEEK SpacerIntervertebral body fusion device , 21 CFR § 888.3080
	6.	AccuLIF TL and PL CageIntervertebral body fusion device , 21 CFR § 888.3080
	7.	AVS® Anchor-L SpacerIntervertebral body fusion device , 21 CFR § 888.3080
	8.	Aero™-AL Lumbar Cage SystemIntervertebral body fusion device , 21 CFR § 888.3080
Product Codes	1.	AVS® AL and AVS® ALign PEEK SpacersMAX
	2.	AVS® PL and AVS® UniLIF PEEK SpacersMAX
	3.	AVS® TL PEEK SpacerMAX
	4.	AVS® Navigator PEEK SpacerMAX
	5.	AVS® ARIA PEEK SpacerMAX
	6.	AccuLIF TL and PL CageMAX
	7.	AVS® Anchor-L SpacerOVD, MAX
	8.	Aero™-AL Lumbar Cage SystemOVD
Predicate Devices		Primary Predicate:AVS® AL and AVS® ALign PEEK Spacers (K093864)
	Additional Predicates:
	AVS® PL and AVS® UniLIF PEEK Spacers (K093704)
	AVS® TL PEEK Spacer (K083661)
	AVS® Navigator PEEK Spacer (K100865)
	AVS® ARIA PEEK Spacer (K101051)
	AccuLIF TL and PL Cage (K141217)
	AVS® Anchor-L Spacer (K120869)
	Aero-AL Lumbar Cage System (K133328)
Device Description	1. AVS® AL and AVS® ALign PEEK SpacersThe AVS® AL (Anterior Large) and AVS® ALign PEEK Spacers areintended for use as interbody fusion devices. They are offered ina variety of lengths, heights and lordotic angles. The hollow, ringshaped implant has serrations on the top and bottom forfixation. The spacers are manufactured from PEEK OPTIMA LT1and include tantalum markers for visualization.
	2. AVS® PL and AVS® UniLIF PEEK SpacersThe AVS® Partial Lumbar (PL) PEEK Spacers and AVS® UniLIF™PEEK Spacers are intended for use as an aid in spinal fixation.This hollow, rectangular implant is offered in a variety of lengths,heights and lordotic angles to adapt to a variety of patientanatomies. It has serrations on the superior and inferior surfacesof the implant designed to help with fixation, an ergonomicallyshaped anterior edge, and a flat posterior edge. Radiopaquemarkers have been embedded within the implant to help allowfor visualization in radiographic images. The spacers aremanufactured from PEEK OPTIMA LT1 and include tantalummarkers for visualization.
	3. AVS® TL PEEK SpacerThe AVS® TL PEEK Spacer is intended for use as an aid in spinalfixation. It is offered in both parallel and wedge shapes. Thehollow implant has serrations on the top and bottom which aredesigned to help with fixation. The spacers are manufacturedfrom PEEK OPTIMA LT1 and include tantalum markers forvisualization.
	4. AVS® Navigator PEEK SpacerThe AVS® Navigator PEEK Spacer is intended for use as aninterbody fusion device. It is offered in a variety of lengths,heights and lordotic angles. The hollow implant has serrations onthe top and bottom for fixation. Radiopaque markers havebeen embedded within the implant to help allow forvisualization in radiographic images. The spacers are
	manufactured from PEEK OPTIMA LT1 and include tantalum
	markers for visualization.
5.	AVS® ARIA PEEK SpacerThe AVS® ARIA PEEK Spacer is intended for use as an interbodyfusion device. It is offered in a variety of lengths, heights andlordotic angles. The hollow, oblong-shaped implant hasserrations on the top and bottom for fixation. The spacers aremanufactured from PEEK OPTIMA LT1 and include tantalummarkers for visualization.
6.	AccuLIF TL and PL CageThe AccuLIF TL and PL Expandable Lumbar Interbody Cages arecrescent and rectangular-shaped titanium implants. Theseimplants are intended for use as interbody fusion devices andare offered in a variety of lengths, footprints, and lordotic anglesdesigned to adapt to different patient anatomies. The implantscan be expanded in height after insertion in the unexpandedstate using the system instrumentation. The implantsautomatically lock at 1mm increments during expansion. Theimplants have serrations on the superior and inferior surfacesdesigned for multidirectional fixation and increased surfacearea for osteointegration, ergonomically shaped anterior edgesto facilitate cage insertion with preservation of endplates andflat posterior edges. The cages have a central openingspanning endplate to endplate for graft containment and topermit fusion through the device. The cages are manufacturedfrom implant grade titanium alloy (Ti-6Al-4V), stainless steel (316LVM), and silicone rubber (MED-4870).
7.	AVS® Anchor-L SpacerThe AVS® Anchor-L Lumbar Cage System consists of a hollow,rectangular-shaped PEEK OPTIMA LT1 cage, titanium alloy (Ti-6Al-4V) bone screws, and a titanium alloy (Ti-6Al-4V) lockingplate. Tantalum markers are included for visualization. It isintended for use as an interbody fusion device and is offered ina variety of heights, footprints, and lordotic angles to adapt tovarying patient anatomies. The AVS® Anchor-L cage consists ofone closed pocket for graft containment and has serrations onthe superior and inferior surfaces of the cage. The implant isdesigned to be used exclusively with the internal supplementalfixation provided.
8.	Aero™-AL Lumbar Cage System
		The Aero™-AL Cage is a hollow, box-shaped PEEK OPTIMA LT1cage surrounded by a titanium alloy (Ti-6Al-4V) jacket. The PEEKcage portion consists of three closed pockets for graftcontainment and has serrations on the superior and inferiorsurfaces of the cage. The cage is designed to be used with theintegrated fixation provided (Aero™-AL Fixation Anchors) inaddition to supplemental fixation systems cleared for use in thelumbosacral spine. The Aero™-AL Fixation Anchors areconstructed from titanium alloy (Ti-6Al-4V) and feature rails thatmate with dovetail channels located within the Aero™-AL PEEKcage. Once fully seated into the channels, the anchors aredesigned to lock into the titanium jacket.
Indications for Use	1.	AVS® AL and AVS® ALign PEEK SpacersThe Stryker Spine AVS® AL and AVS® ALign PEEK Spacers areintervertebral body fusion devices indicated for use withautograft and/or allogenic bone graft comprised of cancellousand/or corticocancellous bone graft when the subject device isused as an adjunct to f usion in patients with degenerative discdisease (DDD) at one level or two contiquous levels from L2 toS1.DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperative
	2.	therapy.The AVS® AL and AVS® ALign PEEK Spacers are to be implantedvia anterior or anterolateral approach.The AVS® AL and AVS® ALign PEEK Spacers are intended to beused with supplemental fixation systems that have been clearedfor use in the lumbosacral spine.AVS® PL and AVS® UniLIF PEEK SpacersThe Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers areintervertebral body fusion devices indicated for use withautograft and/or allogenic bone graft comprised of cancellousand/or corticocancellous bone graft when the subject device isused as an adjunct to fusion in patients with degenerative discdisease (DDD) at one level or two contiguous levels from L2 toS1.
	DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperativetherapy.
	The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers areto be implanted via posterior approach.
	The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers areintended to be used with supplemental spinal fixation systemsthat have been cleared for use in the lumbosacral spine (i.e.,posterior pedicle screw and rod systems).
3.	AVS® TL PEEK SpacerThe Stryker Spine AVS® TL PEEK Spacers are intervertebral bodyfusion devices indicated for use with autograft and/or allogenicbone graft comprised of cancellous and/or corticocancellousbone graft when the subject device is used as an adjunct tofusion in patients with degenerative disc disease (DDD) at onelevel or two contiguous levels from L2 to S1.
	DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperativetherapy.
	The AVS® TL Peek Spacers are to be implanted via posteriorapproach.
	The AVS® TL PEEK Spacers are intended to be used withsupplemental fixation systems that have been cleared for use inthe lumbosacral spine (i.e., posterior pedicle screw and rodsystems).
4.	AVS® Navigator PEEK SpacerThe Stryker Spine AVS® Navigator PEEK Spacers areintervertebral body fusion devices indicated for use withautograft and/or allogenic bone graft comprised of cancellousand/or corticocancellous bone graft when the subject device isused as an adjunct to fusion in patients with degenerative disc

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disease (DDD) at one level or two contiguous levels from L2 toS1.
DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperativetherapy.
The AVS® Navigator PEEK Spacers are to be implanted via aposterior or posterolateral approach.
The AVS® Navigator PEEK Spacers are intended to be used withsupplemental fixation systems that have been cleared for use inthe lumbosacral spine.
5. AVS® ARIA PEEK SpacerThe Stryker Spine AVS® ARIA PEEK Spacers are intervertebralbody fusion devices indicated for use with autograft and/orallogenic bone graft comprised of cancellous and/orcorticocancellous bone graft when the subject device is usedas an adjunct to fusion in patients with degenerative discdisease (DDD) at one level or two contiguous levels from L2 toS1.
DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperativetherapy.
The AVS® ARIA PEEK Spacers are intended to be used withsupplemental fixation systems that have been cleared for use inthe lumbosacral spine.
6. AccuLIF TL and PL CageThe AccuLIF TL and PL Cage are indicated for intervertebralbody fusion with autograft and/or allogenic bone graftcomprised of cancellous and/or corticocancellous bone graftwhen the subject device is used as an adjunct to fusion inpatients with degenerative disc disease (DDD) at one level ortwo contiguous levels from L2 to S1. DDD is defined as back pain

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of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

7. AVS® Anchor-L Spacer

The Stryker Spine AVS® Anchor-L is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone qraft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiquous levels from L2 to S1.

The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach.

The AVS® Anchor-L Lumbar Caqe system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the AVS® Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by AVS® Anchor-L Fixation Screws and Locking Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be used anytime the device is used with any number of screws.

1. Aero™-AL Lumbar Cage System The Stryker Spine Aero™-AL is an intervertebral body fusion

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	device indicated for use with autograft and/or allogenic bonegraft comprised of cancellous and/or corticocancellous bonegraft when the subject device is used as an adjunct to fusion inpatients with degenerative disc disease (DDD) at one level ortwo contiguous levels from L2 to S1.
	DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperativetherapy.
	The AeroTM-AL Lumbar Cage System is to be implanted via ananterior approach.
	The AeroTM-AL Lumbar Cage System is intended to be used withsupplemental spinal fixation systems that have been cleared foruse in the lumbosacral spine (e.g., posterior pedicle screw androd systems) in addition to the included fixation anchors.
Summary ofTechnologicalCharacteristics	The subject Stryker Spine lumbar intervertebral body fusion devicesand the predicate systems share similar design features:
	• Graft windows for packing autogenous and/or allogenic bone
	graft comprised of cancellous and/or corticocancellous bone graft
	when the subject device is used as an adjunct to fusion
	• 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 of
	allogenic bone graft comprised of cancellous and/or
	corticocancellous bone graft as an alternative to autogenous bone
	graft when the subject device is used as an adjunct to fusion. No
	changes have been made to the actual implants.
Summary of thePerformance Data	Published clinical data for lumbar interbody fusion devices similar to
	the Stryker Spine lumbar intervertebral body fusion devices that are
	the subject of this submission was provided in support of this
	application. The published clinical outcomes demonstrated that the
	use of allogenic bone graft comprised of cancellous and/or
	corticocancellous bone graft when the subject device is used as an
	adjunct to fusion in patients diagnosed with degenerative disc
	disease as defined above does not adversely affect performance
	of the system and does not represent a new worst case scenario.
	No changes were made to the existing devices, nor were any new
	components added to the system. Therefore, no additional testing
	was required or performed.
Conclusion	The design features, materials used, manufacturing, and sterilization methods are identical to the previously cleared Stryker Spine lumbar intervertebral body fusion devices with the exception of broadening the indications to include the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
	The data presented in this submission demonstrate that the Stryker Spine lumbar intervertebral body fusion devices that are the subject of this submission with the broadened indications as described above are substantially equivalent to the predicate systems.

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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.