Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape®

Teleflex Polyethylene Sutures are braided, nonabsorbable surgical sutures made from ultra-high molecular weight polyethylene (UHMWPE), available in three variants: standard Polyethylene Suture with a round coreless braid, Polyethylene Fusion Suture that transitions from round to tape to round, and Polyethylene OrthoTape™ Suture with a flat tape design. All variants are indicated for approximation and/or ligation of soft tissues, including use of allograft tissue in orthopedic surgeries.

The subject device is identical to predicate devices in materials, USP performance requirements, sterilization processes, and principles of operation. The primary difference is the addition of two new color additives to the UHMWPE fibers: D&C Violet No. 2 (≤0.2% w/w) and Pigment Green 7/phthalocyanine (≤0.5% w/w), offered in solid or co-braided configurations with nylon, polypropylene, or polyester.

Testing performed per USP standards for suture diameter, needle attachment, tensile strength, and dimensional requirements (height, width, length). Magnetic resonance safety evaluation was also conducted to support MR Safe designation for sutures without needles.

Substantial equivalence is established because the subject device has identical indications for use, same principles of operation, same USP performance requirements, same sterilization processes, and same base materials as predicate devices. The new colorants have been previously cleared for use in UHMWPE sutures with the same indications, and biocompatibility is supported by predicate biological evaluation, raising no new questions on safety or effectiveness.