Shoulder Soft Tissue Anchors

The Shoulder Soft Tissue Anchors are a range of implants manufactured from PEEK OPTIMA LT1 or PEEK/Hydroxyapatite composite, designed to reattach ligament, tendon, or soft tissue to bone in the shoulder joint. They are available in knotted and knotless variants, some preloaded with sutures and preassembled onto drivers, and are indicated for procedures including rotator cuff repairs, Bankart repairs, SLAP lesion repairs, biceps tenodesis, and acromioclavicular separation repairs.

The subject and predicate devices share nearly identical technological characteristics: same indications for use, same materials of manufacture, identical structure support mechanism, same principle of operation, and comparable sizes. The minor differences between subject and predicates do not raise new safety or effectiveness concerns.

ASTM F543 was used as a guide for performance testing. Testing included anchor insertion testing, pull-out testing, torque to failure testing, and fatigue testing to demonstrate sufficient strength for intended use.

The device claims substantial equivalence because it uses the same operating principle, incorporates the same basic design and labeling, and is manufactured and sterilized using the same materials and processes as multiple legally marketed predicate devices (Smith & Nephew Twinfix Ultra, Bioraptor, Stryker Knotilus, KATOR, and Smith & Nephew Healicoil anchors). Non-clinical performance testing confirms the anchor strength is sufficient and equivalent to predicates, and any design differences do not raise new questions of safety and effectiveness.