OSSIOfiber® Interference Screw

The OSSIOfiber® Interference Screw is a biodegradable orthopedic implant made of poly(L-lactide-co-D,L-lactide) reinforced with mineral fibers, designed for fixation of ligaments, tendons, and bones during orthopedic surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist. The device is cannulated and fully threaded (6–12 mm diameter, 23–28 mm length), degrades within approximately 18 months, and eliminates the need for hardware removal surgery.

The OSSIOfiber® Interference Screw has the same intended use, principles of operation, and similar indications as its predicates (Arthrex FastThread K202535 and MILAGRO BR K240441). It is composed of PLDLA with mineral fiber reinforcement, sterilized by ethylene oxide, and available in pediatric-appropriate sizes. Although slight design and material differences exist compared to the primary predicate, mechanical testing demonstrated equivalent performance both initially and after in-vitro degradation.

ISO 9714 compatible instrumentation; ISO 10993 biocompatibility standards (referenced from previously cleared devices K231272, K251309, K243760). Pull-out testing, torsional strength testing, driving torque testing, and in-vitro degradation characterization were conducted.

The device shares identical intended use, material composition, manufacturing and sterilization methods, and principles of operation with reference devices K251309, K243760, and K231272. Mechanical testing demonstrated equivalent or superior pull-out strength and fixation properties compared to the primary predicate K202535, both initially and after degradation. The inclusion of pediatric indications does not alter the intended use or safety profile, as design and performance characteristics are appropriate for both adult and pediatric populations. Biocompatibility is established through ISO 10993 data from previously cleared reference devices.