OSSIOfiber® Suture Anchor

The OSSIOfiber® Suture Anchor is a biodegradable bone fixation device used to attach soft tissue (sutures) to bone in orthopedic procedures across the shoulder, foot/ankle, knee, hand/wrist, and elbow. It consists of an eyelet and anchor body made from poly(L-lactide-co-D,L-lactide) reinforced with continuous mineral fibers that gradually degrade over approximately 18 months, eliminating the need for hardware removal surgery.

The subject device has identical intended use, material composition, design characteristics, principles of operation, and manufacturing/sterilization methods (EtO sterilization) as its predicate device K251309. The primary difference is the addition of pediatric patient populations (children 2-12 years and adolescents 12-21 years) with appropriately sized anchors, though the design and performance characteristics remain unchanged.

ISO 10993 biocompatibility data was referenced from previously cleared devices (K231272, K243760, K252022). No additional mechanical performance testing was conducted because the indications for use do not present a new worst-case scenario compared to the predicate.