Strut Suture; No-Tie Button

The Strut Suture and No-Tie Button are orthopedic fixation devices used in knee ligament and tendon repair procedures. The Strut Suture is a UHMWPE suture with a titanium button anchor for ACL/PCL repair, while the No-Tie Button is a standalone titanium button anchor used with the Strut Suture for ACL/PCL repair or with RootMend MRR for meniscal root repair. Both devices function as fixation posts, distribution bridges, or tension distributors over repair sites.

The devices are composed of uncoated UHMWPE (with UHMWPE tracer material) for the suture and titanium (Ti-6Al-4V) for the button anchor. Both are provided sterile via ethylene oxide sterilization for single use only and are not to be re-sterilized. No notable technical differences were identified compared to the predicate device.

ISO 14937:2009 (sterilization validation), ISO 10993-7:2008 (ethylene oxide sterilization residuals biocompatibility), ISO 10993-1:2009 (biological evaluation), ISO 11607-1:2006 (packaging for sterilized devices), EN 62366-1 (usability engineering testing). Additionally, LAL and rabbit pyrogenicity testing were performed.

The Strut Suture and No-Tie Button have the same intended use, similar principles of operation, and similar technical characteristics as the predicate Arthrex Tight Rope II (K151342), with reference to OrthoButton AL (K230212) and RootMend MRR (K243988). Non-clinical mechanical testing demonstrated performance equivalent to the predicate, and no notable technical differences were identified, therefore raising no issues of safety or effectiveness.