RECLAIM Monobloc Revision Femoral Stem

The RECLAIM Monobloc Revision Femoral Stem is a hip joint prosthesis made of Ti6Al4V alloy designed for cementless implantation in patients undergoing revision hip surgery or total hip replacement. It features a grit-blasted tapered fluted intramedullary region with splines that provide interference fit and bone contact in the femoral canal to restore joint function and mobility.

This submission adds 27 new product codes—four Standard length and twenty-three Short length variants—to an existing RECLAIM Monobloc line. All variants maintain identical material composition (Ti6Al4V), design geometry, tapered fluted intramedullary architecture with splines, and uncemented fixation method as the predicate devices.

Not stated in this summary. The document describes performance testing but does not cite specific ISO, IEC, ASTM, or other consensus standards by name.

The new size variants are substantially equivalent because they share the same intended use (revision hip arthroplasty), indications (cementless treatment of failed prior hip surgery), materials (Ti6Al4V), and method of fixation as predicates K221462 and K231873. Testing confirmed no new worst-case scenarios for neck fatigue or MRI safety, and range-of-motion and stem-fatigue analyses demonstrated performance parity with predicates despite the expanded size range.