STRYKER SPINE AVS ASL PEEK SPACER by STRYKER SPINE

The Stryker Spine AVS™ ASL 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™ ASL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS™ ASL 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 ASL PEEK Spacer is a ring shaped, hollow frame implant with lateral fenestrations, machined from medical grade PEEK OPTIMA LT1. The AVSTM ASL PEEK Spacer incorporates Tantalum marker pins to aid in radiographic visualization. The upper and lower aspects of the AVSTM ASL PEEK Spacer are open, and the superior and inferior surfaces have serrations that assist in the anchorage and seating of the device. The AVSTM ASL PEEK Spacer is offered in both parallel (0°) and wedge (4° & 8°) shapes. These shapes are available in a variety of footprint sizes to fit the anatomical needs of a wide variety of patients.

AI/ML Overview

Analysis of Stryker Spine AVS™ ASL PEEK Spacers (K051205)

The provided document is a 510(k) Summary of Safety and Effectiveness for the Stryker Spine AVS™ ASL PEEK Spacers. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than conducting extensive clinical studies with specific acceptance criteria in the traditional sense of AI/software devices. Therefore, the information typically requested for AI device evaluations (such as acceptance criteria tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is largely not applicable to this premarket notification for a physical medical implant.

Instead, the "acceptance criteria" here are met by demonstrating compliance with FDA's guidance for spinal systems and substantial equivalence to already-marketed predicate devices.

Summary of Acceptance Criteria and Device Performance (as applicable to this type of device):

Acceptance Criteria Category	Acceptance Criteria / Standard	Reported Device Performance / Evidence of Compliance
Material Equivalence	Device material (PEEK OPTIMA LT1, Tantalum marker pins) is comparable to predicate devices.	"Documentation is provided which demonstrates the Stryker Spine AVS™ ASL PEEK Spacer to be substantially equivalent to its predicate devices in terms of its material..."
Design Equivalence	Device design (ring-shaped, hollow frame, lateral fenestrations, serrations, available shapes/sizes) is comparable to predicate devices.	"...design, and indications for use. Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal AVS™ ASL PEEK Spacer."
Indications for Use Equivalence	Device intended use (vertebral body replacement in thoraco-lumbar spine, anterior decompression, height restoration, use with supplemental fixation) is comparable to predicate devices.	"Documentation is provided which demonstrates the Stryker Spine AVS™ ASL PEEK Spacer to be substantially equivalent to its predicate devices in terms of its material, design, and indications for use."
Biocompatibility	Material must be biocompatible for implantation. (Implied by use of PEEK OPTIMA LT1, a commonly accepted medical-grade material, and substantial equivalence to predicates.)	Not explicitly detailed in this summary, but inherent in the use of medical-grade PEEK OPTIMA LT1 and the FDA's acceptance of the 510(k) submission, suggesting standard biocompatibility testing would have been conducted or referenced.
Mechanical Performance / Safety	Device must meet mechanical performance standards for spinal implants (strength, fatigue, stability). Adherence to FDA's Guidance for Spinal System 510(k)'s (May 3, 2004).	"Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal AVS™ ASL PEEK Spacer." This guidance would specify mechanical testing requirements to ensure safety and function.
Radiographic Visualization	Device must be radiographically visible for post-implantation assessment.	"The AVS™ ASL PEEK Spacer incorporates Tantalum marker pins to aid in radiographic visualization."

Study Information (as applicable to this 510(k) document):

2. Sample size used for the test set and the data provenance:

Not Applicable (N/A): This is a 510(k) premarket notification for a physical implant, not a software or AI device. "Test sets" in the context of AI models (e.g., medical images for diagnostic performance) are not used here. The "testing" referred to is mechanical, material, and design verification against established standards and predicate devices. The data provenance would relate to the source of materials, manufacturing processes, and compliance with standards rather than clinical data from human subjects in a "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A: Ground truth in the AI/software sense is not established for this device. Compliance is based on engineering specifications, material properties, and comparison to existing devices.

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

N/A: Not relevant for this type of device submission.

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:

N/A: This is a physical implant, not an AI or diagnostic imaging device. MRMC studies are not applicable.

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

N/A: Not applicable to a physical medical implant.

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

Engineering Specifications and Predicate Equivalence: The "ground truth" for this device's acceptance is its conformity to industry standards (e.g., mechanical testing per FDA guidance for spinal systems) and demonstrating that its material, design, and intended use are substantially equivalent to previously cleared predicate devices. There is no biological "ground truth" in the sense of a disease state being confirmed.

8. The sample size for the training set:

N/A: Not applicable to a physical medical implant. There's no training set for an AI model.

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

N/A: Not applicable to a physical medical implant.

Summary

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NOV - 4 2005

510(k) Summary of Safety and Effectiveness:

Stryker Spine AVSTM ASL PEEK Spacers

Submitter:	Stryker Spine2 Pearl CourtAllendale, New Jersey 07401
Contact Person	Ms. Simona VoicRegulatory Affairs Project ManagerPhone: 201- 760-8145FAX: 201- 760-8345Email: Simona.Voic@stryker.com
Date Prepared	October 21, 2005
Trade Name	Stryker Spine AVSTM ASL PEEK Spacers
Classification Nameand Number	Spinal Vertebral Body Replacement Device,21 CFR 888.3060
Product Code	MQP
Predicate Devices	1) Stryker Spine AVSTM PL PEEK Spacer (K050624)2) Stryker Spine AVSTM TL PEEK Spacer (K042571)3) Stryker Spine Vertebral Spacer (K040731)4) Globus Medical, Inc. SustainTM Radiolucent Spacer (K040284)5) Synthes Spine Vertebral Spacer (K011037)6) Rezaian Spinal Fixator (K841189)7) DePuy AcroMedTM Inc. Surgical Titanium MeshTM System (K003043)8) Surgical Dynamics Mesh Cage System (K003709)
Product Description	The Stryker Spine AVSTM ASL PEEK Spacer is a ring shaped, hollow frame implant with lateral fenestrations, machined from medical grade PEEK OPTIMA LT1. The AVSTM ASL PEEK Spacer incorporates Tantalum marker pins to aid in radiographic visualization. The upper and lower aspects of the AVSTM ASL PEEK Spacer are open, and the superior and inferior surfaces have serrations that assist in the anchorage and seating of the device. The AVSTM ASL PEEK Spacer is offered in both parallel (0°) and wedge (4° & 8°) shapes. These shapes are available in a variety of footprint sizes to fit the anatomical needs of a wide variety of patients.
Intended Use	The Stryker Spine AVSTM ASL 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™ ASL PEEK Spacer is intended for use
	with supplemental fixation. The supplemental fixation systems
	that may be used with the Stryker Spine AVS™ ASL PEEK
	Spacer include, but are not limited to, Stryker Spine plate or rod
	systems (XIA, Spiral Radius 90D, and Trio).
Summary of the	Documentation is provided which demonstrates the Stryker
Technological	Spine AVS™ ASL PEEK Spacer to be substantially equivalent
Characteristics	to its predicate devices in terms of its material, design, and
	indications for use. Testing to demonstrate compliance with
	FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was
	completed for the Stryker Spinal AVS™ ASL PEEK Spacer.

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KOSIZOS

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2005

Simona Voic Regulatory Affairs Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401

Re: K051205

Trade/Device Name: AVS™ ASL PEEK Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: October 21, 2005 Received: October 24, 2005

Dear Ms. Voic:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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- Simona Voic

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson (ما Acting 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): KOS | 7 OS

Device Name: Stryker Spine AVS™ ASL PEEK Spacer

Indications For Use:

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

Page 1 of

510(k) Number K051205

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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.