Resolve Modular Revision Hip Stem

The Resolve Modular Revision Hip Stem is a modular femoral prosthesis designed for primary or revision hip surgery in patients with degenerative joint disease, rheumatoid arthritis, femoral neck fractures, or failed prior hip replacements. It consists of interchangeable proximal components, distal stems, and optional interlocking screws, all made from titanium alloy with optional hydroxyapatite or titanium plasma spray coatings. The device is intended for cementless use only as a single-use implant.

The subject device uses the same Ti-6Al-4V material and modular design philosophy as predicates, with identical operating principles and anatomical application. Coating options (HA/Ti dual spray or Ti single spray) match predicate specifications. Most size variations are bounded by predicate devices; the largest Taper Stem diameter and longest Interlocking Screw lengths represent worst-case extensions that were validated to equivalent performance through non-clinical testing.

ISO 21535 (Range of Motion), ISO 7206-10 (Pull-out Strength), ISO 7206-6 (Neck Fatigue), ISO 7206-4 (Stem Fatigue), ASTM F1875 (Fretting Corrosion), ASTM F543 (Screw Torsional/Mechanical Testing), BS EN 62366-1 (Human Factors), and FDA guidance documents on hydroxyapatite and metallic plasma spray coating characterization.

The device shares identical indications for use, patient population, surgical site, and operating principles with multiple legally marketed predicates. Non-clinical performance testing demonstrated that extended size ranges (e.g., largest Taper Stem diameter, longest Interlocking Screw) achieve equivalent safety and effectiveness to predicate devices through standardized mechanical and fatigue testing. Material composition, sterilization method, and coating specifications are identical to or substantially similar to predicates, and no new risks were identified. The modular architecture and fixation strategy replicate established predicate designs, confirming substantial equivalence despite minor geometric variations.