SF Push-in Anchor

The SF Push-in Anchor is a bioresorbable implant made of Poly-L-lactide-co-D,L-lactide used for soft tissue fixation to bone in orthopedic surgical procedures including ligament reconstruction, tendon repair, and stabilization across the hand, wrist, elbow, knee, hip, shoulder, foot, and ankle. The device is inserted using the SupraFuser ultrasonic generator, which liquefies the polymer at the bone interface to create anchorage.

The subject device differs from the predicate in manufacturing location (Surgical Fusion Technologies GmbH vs. Samaplast AG), sterilization dose (25 kGy vs. 17.5 kGy), post-sterilization molecular weight acceptance criteria (1.0 cm³/g vs. 1.2 cm³/g), shelf-life (3 years vs. 7 years), drill material composition, inclusion of Geomax Reamers for thick cortical bone cases, and software version (V3.1 vs. V2.5). Core function, material composition (PLDLLA), anchor sizes, ultrasonic fixation method, and indications for use remain unchanged.

Not stated in this summary. The document cites only internal testing including gamma sterilization validation, packaging validation, shelf-life validation, and anchor pull-out testing, but does not reference ISO, IEC, ASTM, or other consensus standards.

Substantial equivalence is established because the SF Push-in Anchors have the same intended uses, similar indications, identical technological principles of operation, and identical material composition as the predicate device (K240288). Performance testing confirms equivalent safety and effectiveness despite minor manufacturing and processing differences that raise no new safety or effectiveness concerns.