The SPICCA-SG devices are wedge-shaped anterior cervical interbody fusion cages that are additively manufactured from Ti-6Al-4V ELI Titanium Alloy (ASTM F3001). The cages have a central “bone pocket” that is intended to be filled with autograft or allogenic bone graft. The cages include two pre-assembled PEEK rings (ASTM F2026) that are intended to prevent screw backout. The SPICCA-SG cages are to be anchored with two Ti-6Al-4V ELI Titanium Alloy (ASTM F136) screws. A Ti-6Al-4V ELI Titanium (ASTM F136) locking plate is provided that may be added at the surgeon's discretion. The SPICCA-SG range includes two types of cages - one with screw holes angled towards the midline of the cage and one with screw holes that are parallel to the midline. Each cage type is made available in four footprint and six height options.
The SPICCA-SG Stand-Alone Cervical Fusion Cages are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws and an optional locking plate.