Stryker AlphaVent™ Knotless SP Biocomposite Anchor

The Stryker AlphaVent Knotless SP Biocomposite Anchor is a bone anchor used for soft-tissue to bone fixation across multiple joints including shoulder, knee, ankle, hip, elbow, hand/wrist, and foot in adult and skeletally mature pediatric patients. It consists of a PEEK eyelet attached to a biocomposite anchor body (PLLA/β-TCP) pre-assembled on a disposable stainless-steel inserter that enables self-punching or pilot-hole insertion.

The device is identical to the primary predicate (Stryker AlphaVent Knotless SP PEEK Anchor) in design, intended use, indications, and implantation technique. It shares identical intended use and indications with the secondary predicate (Arthrex SwiveLock Anchor) and uses the same biocomposite material approach as the reference device. The subject device maintains equivalent technological characteristics and performance attributes despite these minor variations across predicates.

Not stated in this summary.

Substantial equivalence is established through non-clinical benchtop testing demonstrating that the AlphaVent Knotless SP Biocomposite Anchor achieves statistically equivalent or superior ultimate tensile strength compared to predicates at multiple timepoints (immediately post-insertion, after cyclic loading, and post-degradation). Successful insertion performance under worst-case conditions and passing bacterial endotoxin testing confirm safety. Since the device is identical in design and use to the primary predicate and raises no new safety or effectiveness questions through rigorous performance testing, it meets the 21 CFR §807.100 criteria for substantial equivalence.