Knotilus+ Biocomposite Knotless Anchor

The Knotilus+ Biocomposite Knotless Anchor is a push-in bone anchor used for soft-tissue to bone fixation in multiple joints (shoulder, knee, foot/ankle, hip, elbow, hand/wrist) in pediatric and adult patients. It comprises a PEEK eyelet with a biodegradable poly-L-lactide and beta-tricalcium phosphate anchor body, pre-assembled on a disposable stainless-steel inserter for single-use applications in various orthopedic repair procedures.

The proposed device is identical to the predicate in intended use, indications, general anchor system design, and operational principle, with the primary difference being substitution of the PEEK anchor body with a biocomposite material (PLLA/β-TCP). Available sizes are 2.4x11.3mm, 2.9x12.5mm, 2.9x15.5mm, and 2.4x8.9mm. Performance testing showed higher pull-out strength compared to predicate devices with successful insertion and passing bacterial endotoxin results.

Not stated in this summary.

The device is substantially equivalent because it maintains identical intended use, indications for use, and general anchor design features as the Knotilus+ PEEK predicate (K232863). The material change from PEEK to biocomposite (PLLA/β-TCP) does not raise new questions of safety and effectiveness, as the biocomposite material is an established implant material already used in legally marketed predicate devices. Benchtop testing confirmed the proposed device demonstrates equivalent or superior performance (higher pull-out strength), successful insertion, and no adverse safety findings compared to predicates.