SuturePatch Tissue Reinforcement

The SuturePatch Tissue Reinforcement is a non-absorbable, permanent surgical mesh made from embroidered polyester yarns with integral reinforcements. It is intended to reinforce and protect soft tissue repairs during tendon surgery, including rotator cuff, patellar, achilles, biceps, and quadriceps repairs. The device works alongside sutures and bone anchors to support healing but does not replace normal body structure or provide full mechanical strength on its own.

The SuturePatch and its predicate (Biomerix Surgical Mesh) share the same basic design, similar materials, performance characteristics, and intended use. Both are non-absorbable surgical meshes for soft tissue reinforcement. The SuturePatch is available in rectangular and trapezoidal patterns with configurable sizes, and sutures can be passed through the mesh using needles or suture passers.

Biocompatibility testing was conducted in accordance with ISO 10993-1:2018. Benchtop performance testing evaluated suture unraveling, suture retention, tensile strength and stiffness, mesh thickness, and density. Animal testing compared tissue ingrowth and mechanical reinforcement to surgical controls.

Arthrex argues substantial equivalence based on identical intended use (soft tissue reinforcement in tendon repair), same fundamental design and materials as the Biomerix predicate, and comparable performance data from benchtop and animal testing. The company states that any differences between the proposed and predicate devices are minor, adequately tested, and do not raise different safety or effectiveness questions. The device shares the same regulatory classification and product codes as existing surgical mesh devices.