MOD-C

The MOD-C is a cervical interbody fusion device indicated for single-level fusion procedures (C2-T1) in skeletally mature patients with degenerative disc disease who have completed at least six weeks of non-operative treatment. The device is composed of an acrylic polymer and synthetic beta-tricalcium phosphate/hydroxyapatite, featuring two hollow chambers to accommodate autogenous or allogeneic bone graft, and must be used with supplemental cervical plate fixation.

The MOD-C has a rounded rectangular footprint (16 mm medial-lateral × 12 mm anterior-posterior) with heights from 5–12 mm in 1 mm increments, offered with parallel or 7° lordotic endplates. The superior and inferior surfaces are serrated to resist migration. The hollow architecture with superior and inferior openings enables bone graft placement. Materials conform to ASTM F3087 (acrylic), ASTM F1088 (beta-TCP), and ASTM F1185 (hydroxyapatite).

ISO 11137-1 and ISO 11137-2 (sterilization validation), USP <85> (endotoxin testing), AAMI TIR12 and TIR30 (instrument reprocessing), ANSI/AAMI/ISO 17665-1 and AAMI ST79 (moist heat sterilization), ASTM F1980 (shelf life), ISO 10993 series (biocompatibility), ASTM F2077 and F2266 (mechanical testing), and ASTM F2267 (subsidence testing).

The MOD-C is substantially equivalent to four predicate devices (K171075, K181115, K142264, K111264) because it shares identical intended use (single-level cervical fusion for DDD), the same operating principles and basic hollow design with serrated endplates, similar material composition and dimensions, and equivalent mechanical performance. No clinical data were required; non-clinical testing demonstrated substantial equivalence through biocompatibility, sterilization validation, mechanical testing, and animal osseointegration studies.