CHENA-C

Cervical PEEK Spacer

CHENA-C® Cervical PEEK Spacer

Purpose

The CHENA-C Cervical Peek Spacer System is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1.

Device Description

The Axis CHENA-C Cervical PEEK Spacer System consists of a variety of footprints and heights of PEEK cervical interbody spacer implants to assist in interbody fusion.

The Axis CHENA-C Cervical PEEK Spacer System implant components are fabricated from medical implant grade Polyetheretherketone and tantalum described by such standards as ASTM F2026-17 and ASTM F560-17. AXIS360 Surgical, Inc. expressly warrants that these devices are fabricated from one of the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

To achieve best results, do not use any of the Axis CHENA-C Cervical PEEK Spacer System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another AXIS360 Surgical’s document. As with all orthopedic and neurosurgical implants, none of the Axis CHENA-C Cervical PEEK Spacer System components should ever be reused under any circumstances.

Indications for Use

The CHENA-C Cervical Peek Spacer System is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies.

The CHENA-C Cervical Peek Spacer is intended for use with autogenous, allograft, demineralized bone graft substitutes, bone graft and supplemental spinal 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. This device is implanted via an anterior approach.

Integrated Hollow Core

The CHENA-C PEEK SPACER is a hollow, ring-shaped PEEK cage with three Tantalum marker pins. The implants are offered in a variety of lengths, heights, and 5° lordotic angle to adapt to varying patient anatomies. The central hole ring-shaped implants have pyramidal serrations on the top and bottom surfaces of the device. The central hole of the implant is intended to hold autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. It is intended for use as an interbody fusion device, (IBD) for the cervical spine (from C2-C3 to C7-T1).

Material: Standard:
Implant Grade PEEK ASTM F2026-17
Tantalum ASTM F560-17

More Information

Instructions for Use
Surgical Technique