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The CHENA-C Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The CHENA-C Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The CHENA-C Spacer is intended to be used with supplemental fixation.

The Kahtnu (previously Axis Orthopaedics) Chena-C Spacer System is consists of a variety of footprints and heights of cervical interbody spacer implants to assist in interbody fusion. The previously cleared Axis Chena Cervical PEEK Spacer System (K181140) implant components are fabricated from medical implant grade Polyetheretherketone and tantalum per ASTM F2026-17 and ASTM F560-17. The purpose of this Special 510(k) submission is to add titanium alloy (ASTM F136) cervical cages to the Chena-C Spacer System.

The KASILOF Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudarthrosis (defined as failed previous fusion).

The KASILOF Cervical Plate System is a plate and screw system composed of medical grade titanium Ti-Alloy (Ti-6A-I4V ELI) components. The titanium plates are available in a variety of lengths, addressing multiple levels of fixation. The plates contain an integrated locking mechanism which interfaces with fixed and variable angled screws, of various diameters and lengths, to accommodate anatomical variation when securing the plate-screw construct to the anterior cervical vertebral bodies. The system is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal cervical spine lordosis, and at the same time eliminate the need for additional plate contouring, KASILOF Cervical Plates come with a pre-lordosed curve. Various instruments are available to facilitate the implantation of the device.