Acu-Sinch Knotless Mini

The Acu-Sinch Knotless Mini is a bone fixation device consisting of two titanium buttons connected by an Ultra High Molecular Weight Polyethylene suture. It is indicated for Carpal Metacarpal joint arthroplasty, providing stabilization at the base of the first and second metacarpal during hematoma distraction arthroplasty after trapezium excision for osteoarthritis.

Both the subject device and predicate device use a two-button suture system to provide fixation between buttons located on the outer cortices of the thumb and index metacarpals. The buttons are titanium alloy (ASTM F136, Ti-6AL-4V ELI) and the suture is UHMWPE. The system distributes suture tension over ligament or tendon repair areas or provides suspensory fixation when the trapezium is removed.

ASTM F2052 (magnetically induced displacement force); ASTM F2119 (MR image artifacts); ASTM F2182 (radio frequency induced heating); ASTM F2213 (magnetically induced torque); LAL and MMP endotoxin testing; static and dynamic fatigue testing; 5-year accelerated and 2-year real-time performance testing.

The subject device is substantially equivalent to the predicate (Arthrex CMC Mini Tightrope, K140328) because both share identical intended use, material technology, operating principles, and anatomical site of implantation. The nonclinical bench testing demonstrated that the Acu-Sinch Knotless Mini performed as well as or better than the predicate in fatigue, MRI safety, and endotoxin testing, establishing equivalent performance without raising different questions of safety or effectiveness.