Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System

The Inion CPS bioabsorbable fixation system comprises plates, screws, and mesh made from degradable polymers (L-lactic acid, D-lactic acid, and either trimethylene carbonate or poly-glycolic acid). These devices are used to fixate bone in craniofacial trauma and reconstructive surgery, including craniotomy flap fixation and bone graft positioning. The implants maintain structural integrity during healing (minimum 70% strength at 6–9 weeks) and fully resorb within 2–4 years.

The application device uses identical material composition, manufacturing methods, and design to the predicate devices. Both versions retain the same bioabsorbable copolymer chemistry, strength retention profiles, and bioresorption timelines as their respective predicates. No changes were made to device materials, construction, or performance specifications.

ISO 10993-1:2018 for biocompatibility evaluation; USP Chapter <161> for endotoxin specification; USP General Chapter <151> for rabbit pyrogen testing; ISO 10993-11:2017 Annex G for material-mediated pyrogenicity detection. Clinical evidence derived from published literature and post-market follow-up data.

The application devices are substantially equivalent because they are composed of identical bioabsorbable polymer materials with no manufacturing changes, retain the same mechanical properties and bioresorption timelines as their predicates, and demonstrate equivalent safety and efficacy through clinical studies (240 patients for Baby 1.5 system; 1755 patients for 1.5/2.0/2.5 system) showing performance rates and complication rates consistent with state-of-the-art devices. The only variation is narrowed indications for neurological procedures versus broader craniofacial indications in the predicates, which represents a narrowing rather than expansion of intended use.