RipCord

The RipCord is a single-use, sterile, non-absorbable implantable device consisting of a far button, ultra-high molecular weight polyethylene (UHMWPE) suture, and a cannulated screw. It is intended to supplement repair or reconstruction during healing of ligament injuries or deficiencies of the extremities, and is used as an adjunct with compatible TriMed fixation implants to provide fixation during healing in syndesmotic trauma, particularly for Weber B and C ankle fractures.

The RipCord Screw is substantially equivalent to the predicate (K220650) in material composition, design features, principles of operation, manufacturing, packaging, and labeling. No differences in technological characteristics are identified that would raise new questions of safety or effectiveness.

TriMed RipCord Screw devices underwent static loading and cyclic endurance testing. TriMed Cannulated Hex 3.2mm screws were tested for torsional strength, driving torque, and axial pullout per FDA Guidance on Orthopedic Non-Spinal Metallic Bone Screws and Washers—Performance Criteria for Safety and Performance Based Pathway.

The device meets established acceptance criteria and demonstrates performance equivalence to the predicate device (K220650) cleared under the same regulatory classification. The RipCord shares identical indications for use (syndesmotic fixation of ligament injuries), the same material and design, and non-clinical testing shows it performs equivalently to the predicate. No new technological differences raise safety or effectiveness concerns.