Y-Knotless™ Flex Anchors

The Y-Knotless™ Flex Anchors are non-absorbable, all-suture knotless implants used to reattach soft tissue (ligaments, tendons, joint capsules) to bone in orthopedic surgery. They are supplied pre-loaded on a disposable driver, sterilized by ethylene oxide, and intended for use in arthroscopic or open procedures including shoulder labrum repair, MPFL reconstruction, foot and ankle, biceps, and meniscal root repair.

The proposed device uses a white flat braided UHMWPE suture anchor with a tapered #2 Hi-Fi® repair suture (green/white/black or white/black) and a #2-0 Hi-Fi® shuttle suture (blue/black), compared to the predicate's two #2 braided suture strands. Both have identical dimensions (1.8mm × 13mm × 0.47mm), use 304 stainless steel shafts and ABS handles, are sterilized via ethylene oxide, and are MR Safe. The proposed device has a 3-year shelf-life versus the predicate's 5-year shelf-life.

ASTM F3960 (performance testing including insertion, ultimate pull displacement resistance, and cyclic loading); ISO 10993-1 (biocompatibility); well-established methods for pyrogen testing, shelf-life validation, sterilization, and post-transportation functional testing.

The Y-Knotless™ Flex Anchors are substantially equivalent to the Y-Knot® Flex All-Suture Anchor predicate (K131035) because they share identical intended use, principle of operation, materials (UHMWPE), dimensions, sterilization method, instrumentation, and performance testing regimen. Design differences (knotless splice loop, single vs. two suture strands, different suture colors) present no new safety or effectiveness issues based on completed performance testing.