TeKBrace Knotless Anchor

The TeKBrace Knotless Anchor is a two-piece PEEK anchor used to attach soft tissue to bone in orthopedic surgery. Available in three sizes (3.9mm, 4.75mm, 5.5mm), it is supplied sterile as part of the TeKBrace System, which pairs the anchor with the TeKBrace Solo Soft Tissue Reinforcement Device. It is indicated for use in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip repair procedures.

The device is a two-component suture anchor manufactured from polyetheretherketone (PEEK) consisting of an eyelet and hollow anchor body. It may be provided preloaded with TeKBrace Solo on an inserter or unloaded in the same packaging. The knotless design eliminates the need for traditional knot-tying during soft tissue fixation.

Mechanical testing was performed in accordance with ASTM F543-07, evaluating insertion and removal torque, torque capacity, and pullout performance before and after fatigue testing, per the Draft Guidance for Premarket Notification (510(k)) for Bone Anchors issued January 3, 2017.

The TeKBrace Knotless Anchor is substantially equivalent to predicate devices (Arthrex SwiveLok, In2Bones Hercules, and Artelon ATL anchors) because it is similar in indications for use, geometry, and materials. Mechanical testing demonstrated comparable performance characteristics, and the TekBrace Solo serves as the functional equivalent of traditional sutures in the anchor/suture construct.