GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor

The GRYPHON X Anchor and HEALIX TRANSTEND Anchor are suture anchors preloaded on disposable inserter assemblies used to fixate suture to bone in various orthopedic procedures. The GRYPHON X is available with multiple suture options (ORTHOCORD, PERMACORD, DYNACORD, PERMATAPE) in single or double strand configurations, offered in absorbable BIOCRYL RAPIDE or non-absorbable PEEK materials with push-in or threaded designs. The HEALIX TRANSTEND is loaded with PERMATAPE 1.3mm suture in PEEK material only.

The anchor design, materials, principle of operation, and intended use are identical to predicate devices. The main differences are additional suture configurations available for GRYPHON X and expanded indications for use for GRYPHON X only, including new procedures in the foot/ankle, knee, and elbow.

Not stated in this summary.

The proposed devices are substantially equivalent because they maintain identical anchor design, materials, operational principles, and core intended use as their predicates. Verification testing demonstrated the devices meet established design inputs and performance criteria with no new safety or effectiveness issues. The additional suture configurations and expanded indications for GRYPHON X do not introduce new technological characteristics—they represent different combinations of existing, proven materials and anchor designs applied to additional but mechanically similar surgical applications.