The Stryker Spine AVS™ TL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS™ TL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

Device Description

The Stryker Spine AVSTM TL Peek Spacer inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in thesurgical correction and stabilization of the spine. The construct is intended for use with supplemental fixation. The device is manufactured from Polyetheretherketone (PEEK) OPTIMA LT1 as described by ASTM F-2026-02. The three (3) Tantalum markers used for this product are made to the standard of ASTM F-560.

AI/ML Overview

The provided text describes a medical device, the Stryker Spine AVS™ TL PEEK Spacer, and its clearance process through a 510(k) premarket notification. However, it does not contain information regarding acceptance criteria, performance data, or a study report in the format typically used to demonstrate a device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against predefined acceptance criteria for a novel device. The document states:

"Documentation was provided which demonstrates the Stryker Spine AVS™ TL PEEK Spacer to be substantially equivalent to its predicate devices in terms of its material, sizes, and indications for use. Testing to demonstrate compliance with FDA's Guidance 'Spinal System 510(k)s', May 3, 2004 was completed for the Stryker Spine AVSTM TL PEEK Spacer."

This indicates that testing was conducted to show compliance with FDA guidance for spinal systems, likely related to mechanical properties, biocompatibility, and other relevant engineering standards, to support the claim of substantial equivalence. However, the specific results of this testing, detailed acceptance criteria for those tests, and information about the study design (like sample size, ground truth, expert qualifications, etc.) are not provided in the given text.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input. The document confirms that testing was done, but does not present the outcomes or the detailed methodology of those tests.

Summary

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510(k) Premarket Notification

K042571

Page 10+2

FEB 1 1 2005

510(k) Summary of Safety and Effectiveness: Stryker Spine AVSTM TL PEEK Spacer

510(k) Submitter:

Stryker Spine 2 Pearl Court, Allendale, New Jersey 07401

510(k) Contact:

Ms. Simona Voic Regulatory Affairs Project Manager Telephone: 201-760-8145/ Fax: 201-760-8345 Email: Simona.Voic@stryker.com

Date Prepared:

December 30, 2004

Proprietary Trade Name: Stryker Spine AVS™ TL Peek Spacer

Common Name: Vertebral Body Replacement

Classification Name and Reference:

Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3060

Device Panel/ Product Code:

MOP: Spinal Vertebral Body Replacement Device

Predicate Devices:

Stryker Spine Vertebral Spacer [K040731] DePuy AcroMed TM , Inc. Surgical Titanium Mesh TM System [K003043] Medtronic Sofamor Danek VERTE-STACK™ Spinal System [K031780] Rezaian Spinal Fixator [K841189]

Product Description:

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Indications:

The Stryker Spine AVS™ TL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant. The Stryker Spine AVS™ TL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS™ TL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

Summary of the Technological Characteristics:

Documentation was provided which demonstrates the Stryker Spine AVS™ TL PEEK Spacer to be substantially equivalent to its predicate devices in terms of its material, sizes, and indications for use. Testing to demonstrate compliance with FDA's Guidance "Spinal System 510(k)s", May 3, 2004 was completed for the Stryker Spine AVSTM TL PEEK Spacer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human figures or flowing lines.

Public Health Service

FEB 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Spine C/o Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

Re: K042571

R042371
Trade/Device Name: Stryker Spine AVSTM TL PEEK Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: January 7, 2005 Received: January 10, 2005

Dear Ms. Voic:

We have reviewed your Section 510(k) premarket notification of intent to market the device in the We have reviewed your Secures 110(x) premium in the midications for use stated in the above and liave actemmed the devices marketed in interstate commerce prior to enclosure) to regally marketcu predical Device Amendments, or to devices that have been May 28, 1976, the enatified tate of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the premarket approval application (PMA). You may, therefore, market the A do not require approval of a premarket approval approval controls provisions of the Act. device, subject to the gelleral controls of the rice real 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 If your device is classified (see above) and since major regulations affecting your device can be found in
be subject to such additional controls. Existing major regulation be subject to such additional controls. Diabang and one of the may publish further
the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish the Code of Fouceming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that PDA s issumic of a successions of the requirements of the Act or any FDA has made a determination that your device Federal agences. You must comply with all the Federal statures and Tegulations administer of OFFA Part 807); abeling (21 CFR Part 807); abeling (21
Act 's requirements, including, but not limited to: registration awality CFR Part 801), good manufacturing practice requirements as set forth in the quality systems (QS) CFK Part 801), good mandracturing product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Simona Voic

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket I his letter will anow you to began marketing your device to a legally marketed predicate notification. The rDA indusg of substantial equind this, 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 II you desire specific acries is 1940 (276-0120. Also, please note the regulation entitled, Comact the Office of Complanoe at (210) 276 City (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, gelleral information on your respensionalises at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millan

Celia M. Witten, Ph.D., M.D. 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): K042571

Device Name: Stryker Spine AVS 100 TL PEEK Spacer

Indications For Use:

The Stryker Spine AVS™ TL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS 100 TL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

Prescription Use × (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)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number_ K042571

Page 1 of 1

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.