BioBrace ® RC Delivery System

The BioBrace® RC Delivery System is a sterile, single-use surgical mesh designed to reinforce soft tissue during rotator cuff tendon repair. It consists of a bioresorbable collagen-PLLA implant pre-stitched with suture, a threader assembly, and a disposable inserter to facilitate placement into the subacromial space. The implant is not intended to provide full mechanical strength but rather to supplement sutures and bone anchors in supporting the repair.

The proposed device adds a sterile disposable deployer instrument to the predicate BioBrace Implant. Both use identical collagen-PLLA mesh (80% porosity, 3mm thick) in the same sizes (23×25mm and 35×25mm), identical sterilization (ETO, SAL 10⁻⁶), biocompatibility per ISO 10993-1, and single-use sterile supply. The proposed device has extended shelf-life (12 months vs. 6 months) and modified packaging. The inserter is the primary technological addition to facilitate clinical delivery.

ISO 10993-1 for biocompatibility. The document cites testing for biocompatibility, packaging, sterilization, shelf-life, transportation, performance, and user validation, though specific test standards (ASTM, IEC) are not explicitly named.

The proposed device is substantially equivalent because it uses the identical predicate implant material, geometry, sterilization, and biocompatibility profile. The addition of a sterile disposable deployer for delivery does not introduce new safety or efficacy concerns—it is a facilitative instrument analogous to delivery tools for other surgical meshes. Both devices have the same intended use (rotator cuff reinforcement), same contraindications, same mechanism (soft tissue reinforcement via sutures/anchors), and equivalent performance testing demonstrates comparable safety and effectiveness. The deployer is a convenience feature that does not alter the implant's biological or mechanical function.