The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft 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 PL PEEK. Spacers are to be implanted via posterior approach.

The AVS PL 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).

Device Description

The subject AVST™ PL PEEK Spacers and the predicates AVST™ PL PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., Brantigan Cage) share similar design features:
• Hollow frame PEEK Implant
• Lateral fenestrations
• Serrations on the superior and inferior surfaces
• Comparable heights, widths, and angles
• Materials and mechanical testing results are similar between the subject device and the listed predicates.

This Special 510(k) premarket notification is intended to introduce the following modifications to the AVSTM PL PEEK Spacers approved under K073470, K080758, and K082014:

A range of 0° and 4° AVSTM PL PEEK Spacers (6-13mm in height, 30 and 33mm lengths with an 11mm width) were found to be substantially equivalent to the Brantigan Cage in K073470. In K080758, minor design changes were introduced to the 0° degree spacers. K082014 added four (4) implants in a 14 mm height. The minor design modifications approved under K080858 had been incorporated in these 14 mm implants.

The AVSTM PL PEEK Spacers that are the subject of this application add the design modifications that were approved on the 0 ° implants under K080758, to the 4 ° implants previously approved under K073470 and K082014. The lengths, width, and angles are the same as the predicate AVS® PL PEEK Spacers previously approved. The modifications include replacing the ogival shaped nose of the implant with the wedge-shaped design to facilitate insertion of the spacer between adjacent vertebral endplates. The threaded hole on the front side was removed as it is not needed to retrieve the implant and field feedback has confirmed that it would likely not be used. In the smaller heights, the back side threaded hole has been adapted to the various heights of the spacers to remain consistent with the existing instruments (i.e., the two Inserters), and the back side of the spacer has been tapered in the frontal plane to match the geometry of the vertebral endplates and the size of the two flat surfaces has been increased to improve the connection with the Inserters.

Note that the AVS™ PL PEEK Spacers may also be referred to as AVS™M Plus or UniLIF.

AI/ML Overview

This document describes a Special 510(k) Premarket Notification for modifications to the AVS™ PL PEEK Spacer System, an intervertebral body fusion device. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, not to establish new clinical efficacy or safety claims through a clinical study with acceptance criteria.

Therefore, many of the requested categories in your prompt are not applicable to this type of submission. This document primarily focuses on demonstrating that the modified device is still substantially equivalent to the original cleared device and previously cleared predicate devices based on design features, materials, and mechanical testing, rather than reporting on a study designed to establish performance against specific acceptance criteria for a novel device.

Here's an analysis based on the provided text, indicating where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not applicable in the context of this 510(k) submission. This is a Special 510(k) for modifications to an already cleared device, demonstrating substantial equivalence rather than presenting performance against new clinical acceptance criteria through a clinical trial. The text states:

"Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems."

This indicates that mechanical and material testing was performed to show the modified device performs similarly to the predicate devices, not to meet specific clinical acceptance criteria.

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

This information is not provided in the document. As this is a submission for device modifications and substantial equivalence, detailed clinical study data with test sets and provenance are not typically required or included. The "test set" would primarily refer to physical devices subjected to mechanical testing.

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

This information is not applicable/not provided. There was no clinical "test set" in the sense of patient data requiring expert ground truth establishment for performance evaluation.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of AI assistance on human reader performance, which is not relevant for this medical device (spinal intervertebral body fusion device).

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI algorithm.

7. The Type of Ground Truth Used:

This information is not applicable. For this device, "ground truth" would relate to the physical and mechanical properties of the device (e.g., strength, durability, biocompatibility), which are assessed through engineering and material testing, not through expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic clinical study. The "ground truth" for showing substantial equivalence relies on comparing the modified device's characteristics to those of the predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. This submission does not involve an AI algorithm that requires a training set.

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

This information is not applicable. No AI algorithm with a training set requiring ground truth establishment was involved.

In summary, this 510(k) submission is for demonstrating substantial equivalence of a modified intervertebral body fusion device to existing predicate devices, primarily through engineering and material testing. It does not involve algorithms, clinical trials with specific acceptance criteria for performance, or human-in-the-loop studies as typically seen with diagnostic AI devices.

Summary

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K090816 Page 1 of 3

AVSTM PL PEEK Spacer System, Line Extension

Special 510(k) Premarket Notification

Special 510(k) Summary of Safety and Effectiveness:

Modifications to the AVS™ PL PEEK Spacer System

Proprietary Name:	AVST™ PL PEEK Spacer System	APR 24 2005
Common Name:	Spinal Fixation Appliances
Proposed Regulatory Class:	Class II
	Interevertebral body fusion device21 CFR 888.3080
Device Product Code:	MAX
For Information contact:	Vikki M. O'ConnorRegulatory Affairs Project Manager2 Pearl CourtAllendale, NJ 07401Telephone: (201) 760-8215Fax: (201) 760-8415Email: Vikki.O'Connor@Stryker.com
Date Summary Prepared:	March 18, 2009
Predicate Device	AVST™ PL PEEK Spacers (K073470, K080758 and K082014)DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP SpineSystem: P960025 (i.e., Brantigan Cage)
Predicate Device Information	The subject AVST™ PL PEEK Spacers and the predicatesAVST™ PL PEEK Spacers and DePuy's Lumbar I/F Cage (i.e.,Brantigan Cage) share similar design features:• Hollow frame PEEK Implant• Lateral fenestrations• Serrations on the superior and inferior surfaces

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K090816 Page 2 of 3

AVSTM PL PEEK Spacer System, Line Extension

Special 510(k) Premarket Notification

· Comparable heights, widths, and angles
· Materials and mechanical testing results are similar between the subject device and the listed predicates.

This Special 510(k) premarket notification is intended to introduce the following modifications to the AVSTM PL PEEK Spacers approved under K073470, K080758, and K082014:

Description of Device Modification

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K090816

AVSTM PL PEEK Spacer System, Line Extension

Special 510(k) Premarket Notification

the geometry of the vertebral endplates and the size of the two flat surfaces has been increased to improve the connection with the Inserters.

Note that the AVS™ PL PEEK Spacers may also be referred to as AVS™M Plus or UniLIF.

The Stryker Spine AVS™ PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

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

The AVSTM PL 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).

Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems.

Intended Use

Summary of the Technological Characteristics

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the left side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Corporation % Ms. Vikki M. O'Connor Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

APR 2 4 2009

Re: K090816

Trade/Device Name: Stryker Spine AVS PL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Product March 23, 2009 Received: March 25, 2009

Dear Ms. O'Connor:

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 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 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. Vikki M. O'Connor

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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

510(k) Number (if known): K_090 8 / طا

Device Name: Stryker Spine AVS PL PEEK Spacers

Indications For Use:

The AVS PL PEEK. Spacers are to be implanted via posterior approach.

The AVS PL 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).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

neral, Restorative, and Neurological Devices

510(k) Number K090811

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.