Skyway Anterior Cervical Plate System

The Skyway Anterior Cervical Plate System is an anterior cervical spine fixation device composed of titanium alloy plates, bone screws, and a locking screw. It is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion to treat degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis, and failed previous fusion. The 4-hole 1-level plates can be permanently attached to Tesera-k SC interbody spacers for supplemental fixation.

The subject device adds non-sterile packaged plate options to the previously cleared sterile-only configuration and modifies the geometry of the plate's screw holes and screw heads with minor dimensional changes. The material remains titanium alloy Ti-6Al-4V ELI per ASTM F136. The device is offered in various sizes to accommodate patient anatomical needs.

ISO 17665-1 was referenced for sterilization adoption evaluation of the non-sterile plate configuration using a worst-case sterilization set.

The predicate device K243015 (also Skyway Anterior Cervical Plate System by the same manufacturer) has the same intended use, material composition, and basic design. The modifications—adding non-sterile packaging options and making minor dimensional changes to screw holes and screw heads—do not raise new questions about safety or efficacy. The sterilization validation per ISO 17665-1 confirms the non-sterile options can be properly sterilized. No performance testing was required because these are minor modifications to an existing, already-cleared design.