Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners

The Trabecular Metal Acetabular Revision System (TMARS) Acetabular Liners and Constrained Liners are polyethylene/metal hip socket liners manufactured from Longevity highly cross-linked ultra-high molecular weight polyethylene (UHMWPE). The acetabular liners are indicated for cemented use to replace worn or damaged bearing surfaces; the constrained liners are indicated for complex primary or revision hip patients at high risk of dislocation.

The subject device has identical intended use, indications for use, raw materials, design features, and packaging as the predicate devices. The only difference is the sterilization method, though the sterility assurance level remains identical to the predicate.

ISO 10993-1 (biocompatibility testing), Good Laboratory Practices (21 CFR 58), and ASTM F648 (material properties standards for polyethylene liners).

Substantial equivalence is established through comprehensive non-clinical testing demonstrating comparable performance: lever-out, torque-out, dynamic impingement, push-out, pull-out, wear, and range of motion tests all showed the device performs equivalently to the predicate. Biocompatibility testing per ISO 10993-1 passed without unexpected results, and material properties conform to ASTM F648, matching the predicate specifications. The alternative sterilization method does not affect the final sterility assurance level.