SnugFit ASA Extension

The SnugFit ASA Extension is a soft tissue fixation device composed entirely of ultra-high molecular weight polyethylene (UHMWPE) and polyester sutures braided to create an anchoring point in bone. It is intended for arthroscopic or open surgical fixation of soft tissue to bone in the hip (acetabular labral repair) and shoulder (glenoid labrum repair, rotator cuff repair, biceps tendon repair). The device consists of a pre-loaded all-suture anchor on a disposable stainless-steel driver with plastic handle.

The subject and predicate devices are substantially equivalent in indications for use, sizes, deployment and fixation mechanism, driver design, materials, biocompatibility, device usage, packaging, shelf-life, and sterilization. The only difference is the type and number of preloaded sutures—the subject devices expand the portfolio with new single-loaded, double-loaded, and triple-loaded configurations across Size 1 and Size 2 variants.

European Pharmacopoeia §2.6.14 (bacterial endotoxin/LAL test, equivalent to USP chapter <85>) and USP chapter <151> (pyrogen test) were used for pyrogenicity determination. Performance testing and biocompatibility assessment were conducted according to written protocols, though specific ISO/IEC/ASTM standards are not cited by name in this summary.

Substantial equivalence is supported because the functional mechanism is identical to the predicate devices (K230544, K203485)—the sutures anchor identically in bone and secure soft tissue the same way. The only change is the number and arrangement of preloaded sutures, which expands surgeon choice but introduces no worse-case performance; pull-out force testing confirms equivalence. Since materials, design, sterilization, biocompatibility, and shelf-life are unchanged, and the indications for use remain identical, the device poses no new safety or effectiveness risks compared to already-cleared predicates.