AVS ANCHOR-C CERVICAL CAGE SYSTEM
Device Facts
| Record ID | K102606 |
|---|---|
| Device Name | AVS ANCHOR-C CERVICAL CAGE SYSTEM |
| Applicant | Stryker Spine |
| Product Code | OVE · Orthopedic |
| Decision Date | Apr 22, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3080 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The AVS® Anchor-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior approach. The AVS® Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Device Story
AVS® Anchor-C Cervical Cage System is an interbody fusion device for anterior cervical spine surgery. Device consists of a hollow, rectangular PEEK Optima® LT1 cage with a titanium alloy (Ti6Al4V) plate and tantalum marker. System includes titanium alloy fixation screws that lock into the cage plate to provide internal supplemental fixation. Implant is packed with autogenous bone graft to facilitate fusion. Used by surgeons via open, anterior approach. Device provides structural support and stabilization to the intervertebral space, promoting fusion in patients with symptomatic cervical disc disease. Variety of heights, footprints, and lordotic angles available to match patient anatomy.
Clinical Evidence
Bench testing only. No clinical data provided. Mechanical testing performed per ASTM standards: static/dynamic compression, static/dynamic compression shear, static/dynamic torsion, expulsion, and subsidence.
Technological Characteristics
Materials: PEEK Optima® LT1 (ASTM F2026), Titanium alloy Ti6Al4V (ASTM F136, ISO 5832-3), Tantalum (ASTM F560). Design: Hollow cage with graft window, superior/inferior surface serrations, integrated titanium plate and locking screw fixation. Mechanical testing: ASTM F2077, ASTM F2267, ASTM F04-25-02-02.
Indications for Use
Indicated for anterior cervical interbody fusion in skeletally mature patients with cervical disc disease (intractable radiculopathy/myelopathy, herniated disc, or osteophyte formation with nerve root/spinal cord compression) at one level from C2-C3 to C7-T1. Requires six weeks of prior non-operative treatment.
Regulatory Classification
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.
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