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AVS Anchor-C Cervical Cage System

by Stryker Spine

510(k) K102606

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102606 Date22 Apr 2011ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3210-2024 FDA Class II initiated 23 Aug 2024

    Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OVE
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The AVS Anchor-C Cervical Cage System is a standalone interbody fusion device classified as an Anterior Cervical Fusion Device (per FDA nomenclature). It features a hollow polyetheretherketone (PEEK) cage with an integrated titanium screw locking mechanism, providing rigid fixation for cervical spine stabilization. Designed for use in anterior cervical discectomy and fusion (ACDF) procedures, it facilitates bone graft containment and spinal alignment without increasing anterior profile. The device is intended to aid in achieving cervical fusion through internal screw fixation.

The system is supplied sterile and intended for single-use. It is approved for use in the United States under FDA 510(k) clearance (K102606) as substantially equivalent to predicate devices. The AVS Anchor-C includes angled and flexible instrumentation for intuitive handling, along with a self-locking screw mechanism to secure the cage in place. Storage and handling follow standard orthopedic implant protocols, ensuring sterility and compatibility with MRI-safe environments. No additional regulatory markings beyond the FDA clearance are stated.

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Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of cervical spine procedures is the AVS Anchor-C Cervical Cage System designed to assist with, and how does it help in those procedures?

    The AVS Anchor-C Cervical Cage System is specifically designed to aid in anterior cervical discectomy and fusion (ACDF) procedures. It provides rigid fixation through its hollow PEEK cage and integrated titanium screw locking mechanism, which helps contain bone graft material while maintaining spinal alignment. Unlike traditional cages, it does not increase the anterior profile, making it suitable for procedures where minimizing soft tissue disruption is important.

  • Is the AVS Anchor-C Cervical Cage System reusable, or is it intended for single-use only? How should it be stored to maintain sterility?

    The AVS Anchor-C Cervical Cage System is intended for single-use only and is supplied sterile. To preserve sterility, it should be stored according to standard orthopedic implant protocols, typically in a sealed, sterile packaging until immediately before use. Avoid exposure to moisture, contamination, or excessive handling to prevent compromise of its sterile condition.

  • What materials is the AVS Anchor-C Cervical Cage System made from, and does it have any special features for stability or ease of use?

    The cage itself is made from polyetheretherketone (PEEK), a biocompatible material that provides structural integrity while being radiolucent for better imaging. It includes an integrated titanium screw locking mechanism for rigid fixation, along with angled and flexible instrumentation to improve handling during surgery. These features work together to secure the cage in place and facilitate intuitive placement.

  • Are there different sizes or models of the AVS Anchor-C Cervical Cage System, and if so, how are they determined?

    While the provided data does not specify exact sizes or models, the AVS Anchor-C system is designed to accommodate various cervical spine segments. Typically, such systems offer multiple cage heights and widths to match anatomical requirements, though precise dimensions would require consulting the manufacturer’s technical documentation or product catalog. The system’s flexibility in instrumentation also aids in adapting to different surgical needs.

  • Can the AVS Anchor-C Cervical Cage System be used in environments where MRI scans are required, and how does it handle in those settings?

    Yes, the AVS Anchor-C Cervical Cage System is compatible with MRI-safe environments. The materials used—PEEK and titanium—are non-ferromagnetic, reducing the risk of artifacts or interference during MRI scans. However, always follow the manufacturer’s guidelines for MRI safety, as imaging protocols may vary based on specific scanner settings and clinical protocols.