Anchor with Fiber Wire and Disposable Inserter

The Ortobio Anchor with Fiber Wire and Disposable Inserter is a sterile, single-use bone anchor made from titanium alloy with preloaded ultra-high molecular weight polyethylene (UHMWPE) sutures. It is intended for soft tissue fixation to bone in various orthopedic procedures including rotator cuff repair, ligament reconstruction, and tendon repair in the shoulder, elbow, knee, hand, wrist, foot, and ankle.

The device is manufactured from titanium alloy (ASTM F136) with an external threaded portion and hexagonal head designed for suture passage. It uses UHMWPE sutures (size 2, 0.5 mm) fixed by integrated eyelets and comes preassembled into a disposable applicator with a stainless steel shaft and polypropylene handle. Available anchor diameters range from 1.7 mm to 5.5 mm, overlapping with predicate device dimensions.

ISO 5832-3:1997 (titanium alloy material), ISO 11135:2014 (sterilization to SAL of 10⁻⁶), ISO 10993-1 (biological evaluation), ASTM F136 (titanium material specification), ASTM F899 (stainless steel needles), and FDA guidance on bone anchors, magnetic resonance compatibility, and surgical sutures. Performance testing included insertion torque, pullout, and fatigue testing per ASTM standards.

The subject device is substantially equivalent to predicate devices K223114 (HTA Headless Titanium Anchor and ZIP Anchors) and K201083 (Parcus suture anchors) based on identical intended use for soft tissue fixation, same principle of operation, equivalent materials (titanium alloy and UHMWPE sutures), equivalent sterilization and single-use status, and comparable or non-inferior mechanical performance demonstrated by statistical non-inferiority testing. Minor differences in dimensions and suture sizes fall within the range of predicates and do not raise new safety or efficacy concerns.