Tigon Medical Knotless and Dual Javelin All-Suture Anchors

The Tigon Medical Knotless and Dual Javelin All-Suture Anchors are soft tissue fixation devices used to reattach tendons and ligaments to bone across multiple anatomical sites including the shoulder, elbow, knee, hip, foot/ankle, hand/wrist, and other areas. The devices enhance surgical efficiency by eliminating the need for knot tying, with the Dual Javelin variant creating a double-socket knotless construct. They are permanent, non-degradable UHMWPE anchors available in three sizes, preloaded on reusable stainless steel inserters, and deployed via self-punching or drilling beneath the cortical bone layer.

The candidate devices are made of UHMWPE per ASTM F2848 and are substantially equivalent to predicates in materials composition, size range (1.6 mm, 2.3 mm, 2.6 mm), method of fixation (self-punching or drilling deployment), and mechanical strength. They feature various load configurations with suture options including USP 2 suture cable, 1.5 mm suture tape, USP 5 suture cable, and/or 2 mm suture tape, and are provided EtO sterilized for single-use in surgical settings.

Comparative mechanical testing was performed according to ASTM F3690-24 and ASTM F543, including fatigue testing, displacement after fatigue testing, and axial pull-out testing. The device materials comply with ASTM F2848 for UHMWPE specifications.

Substantial equivalence is established because the candidate devices have equivalent intended use and indications as the predicate devices (Tigon Medical All-Suture Anchors K242529), and major technological characteristics are substantially equivalent including materials, size range, method of fixation, and mechanical strength. Mechanical test data demonstrates performance substantially equivalent to the predicate device.