PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture

PINION™ PDO and PINION™ PGA-PCL Knotless Sutures are sterile, absorbable monofilament surgical sutures with barbs that allow tissue approximation without tying knots. The PDO suture is made of polydioxanone and the PGA-PCL suture is made of a copolymer of glycolide and caprolactone, both available in multiple sizes with attached stainless steel needles.

The subject devices maintain identical material composition, intended use, mechanism of action, and barb design (unidirectional and bidirectional) as their predicates. The primary modification is expansion of available suture sizes: PINION™ PDO now ranges from 5-0 to 2 (predicate was 3-0 to 0), and PINION™ PGA-PCL now ranges from 4-0 to 2 (predicate was 4-0 to 2-0). Barb angles and heights for new sizes were specified according to USP standards.

USP <861> (Diameter), USP <881> (Tensile Strength), USP <871> (Needle Attachment), ISO 10993-1 (Biocompatibility), EN ISO 10993-1:2020, and FDA's Surgical Sutures Class II Special Controls Guidance Document (June 2, 2003). Testing included sterility per USP <71>.

The expanded size range is substantially equivalent because all additional sizes undergo testing per the same USP and ASTM standards as the cleared predicate, with results meeting pre-defined acceptance criteria. Biological safety, shelf-life, packaging integrity, labeling, and sterilization method remain unchanged. The new sizes are consistent with USP specifications and follow the same tensile-strength-to-size equivalency model (one size smaller after barbing to match knot-pull tensile strength of a non-barbed equivalent). No changes to fundamental design, material, or intended use were made.