OSSIOfiber® Threaded Trimmable Fixation Nail

The OSSIOfiber® Threaded Trimmable Fixation Nail is a degradable bone fixation implant made of poly(L-lactide-co-D,L-lactide) reinforced with mineral fibers. It is used to maintain alignment and fix bone fractures, osteotomies, arthrodesis, and bone grafts in the upper extremity, fibula, knee, ankle, and foot in adults and children with fused growth plates. The implant degrades over approximately 18 months, eliminating the need for hardware removal surgery.

The subject devices have identical intended use, indications for use, material composition, principles of operation, manufacturing and sterilization methods (EtO sterilization) as the primary predicate (K241277) but are larger and longer (70-100 mm long, 7.0 mm diameter). They share similar design characteristics with the additional predicate OSSIOfiber® Compression Screw (K231272), with differences limited to size outside the previously cleared range.

ISO 10993 (biocompatibility), ISO 9714 (compatible instruments), in-vitro degradation profile testing, torsional strength testing, driving torque testing, flexural bending properties testing, and axial pull-out strength engineering analysis.

The devices are substantially equivalent because they have identical intended use, indications, material composition, manufacturing and sterilization methods as the primary predicate K241277, with only size differences. The additional sizes do not introduce a new performance worst-case, and confirmatory testing (torsional strength, driving torque, and axial pull-out analysis) demonstrates equivalence to both predicates. The larger sizes are similar to those of the additional predicate K231272, and the devices do not alter intended surgical use or affect safety and effectiveness when used as labeled.