Search Results

The DePuy/Ace MMA Fracture Stem is indicated for cemented or press-fit cementless use as the femoral component in total hip arthroplasty (THA) for replacing the hip joints of patients whose hip joint has been damaged by fracture. The prosthesis may also be used for total hip arthroplasty for patients requiring total hip replacement for inflammatory or non-inflammatory degenerative joint disease or failure of a previous arthroplasty.

The DePuy/Acc MMA Fracture Stem is a cast Co-Cr-Mo hip stem with a bead blasted finish. The stem has a triangular proximal body, a rounded shoulder, a straight distal stem, and anterior and posterior grooves that extend from the distal tip up approximately 60% of the length of the stem. Five sizes are available, ranging from 9 to 16.5mm in diameter. The DePuy/Ace MMA Fracture Stem has an Articul-eze (12/14) taper and is only to be used with the DePuy Co-Cr-Mo or Zirconia Articul-eze taper modular femoral heads (cleared in K883460 and K952088).

This K964704 document describes a medical device, the DePuy/Ace MMA Fracture Stem, and its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, device performance statistics from a study, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document focuses on comparing the new device's design and intended use to existing, cleared devices to establish substantial equivalence, which is a regulatory pathway that often relies on demonstrating similar performance characteristics (e.g., fatigue strength in this case) rather than new clinical trials with detailed statistical performance metrics as might be found for AI-driven diagnostic devices.

Ask a specific question about this device