← Product Code [ODP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/ODP) · K142251 # AVS AS PEEK Spacer (K142251) _Stryker Corporation · ODP · Nov 19, 2014 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/ODP/K142251 ## Device Facts - **Applicant:** Stryker Corporation - **Product Code:** [ODP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/ODP.md) - **Decision Date:** Nov 19, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3080 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use 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 Story Hollow, ring-shaped PEEK interbody fusion spacer; includes Tantalum marker pins; features serrated superior/inferior surfaces for fixation; hollow center holds autogenous or allogenic bone graft. Implanted via open, anterior cervical approach by surgeons; used with supplemental cervical fixation systems. Device maintains disc space height and facilitates fusion in DDD patients. No changes to physical implant design; submission expands indications to include allogenic bone graft usage. ## Clinical Evidence No new clinical testing performed. Evidence provided via published clinical literature regarding the use of allogenic bone graft (cancellous/corticocancellous) in anterior cervical interbody fusion procedures, demonstrating safety and effectiveness comparable to autograft. ## Technological Characteristics Material: PEEK Optima® LT1 (ASTM F2026) with Tantalum marker pins (ASTM F560). Design: Hollow, ring-shaped cage with serrated surfaces. Dimensions: Various lengths, heights, and lordotic angles. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Stryker Spine, AVS® AS PEEK SPACER ([K120486](/device/K120486.md)) - Medtronic Sofamor Danek, ANATOMIC PEEK CERVICAL FUSION SYSTEM ([K130177](/device/K130177.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profile graphic. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K142251 Device Name AVS® AS PEEK Spacer #### Indications for Use (Describe) 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. #### 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 Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | 510(k) Summary: Expanded Indications for Use, Stryker Spine AVS® AS PEEK Spacer | | |---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Stryker Spine
2 Pearl Court
Allendale, NJ 07401 | | Contact Person | Garry T. Hayeck, Ph.D.
Senior Regulatory Affairs Specialist
Phone: 201-760-8043
Fax: 201-962-4043
E-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 to
the devices listed below:
Primary Predicate Device:
Stryker Spine, AVS® AS PEEK SPACER, K120486
Additional Predicate Device:
Medtronic Sofamor Danek, ANATOMIC PEEK CERVICAL FUSION
SYSTEM, K130177 | | 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. | | Indications for Use | 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. | | | 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. | | Summary of
Technological
Characteristics | The subject AVS® AS PEEK Spacer and the predicates share similar
design 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 of
allogenic bone graft comprised of cancellous and/or
corticocancellous bone graft as an alternative to autogenous bone
graft. No changes have been made to the actual implants. | | Summary of the
Performance Data | Published clinical data for the cervical interbody fusion devices similar
to the AVS® AS PEEK Spacer 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 in anterior cervical interbody fusion
procedures to treat patients diagnosed with cervical 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 AVS® AS PEEK Spacer
components with the exception of broadening the indications to
include the use of allogenic bone graft comprised of cancellous
and/or corticocancellous bone graft as an alternative graft material.

The data presented in this submission demonstrates that the safety
and effectiveness of the AVS® AS PEEK Spacers when used with
allogenic bone graft comprised of cancellous and/or
corticocancellous bone graft is substantially equivalent to the safety
and effectiveness of the predicate systems when used with autograft. | {4}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/ODP/K142251](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/ODP/K142251) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com