(60 days)
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.
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K964704
SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 2 4 1997
| NAME OF FIRM: | DePuy Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988 |
|---|---|
| 510(k) CONTACT: | Cheryl HastingsManager, Clinical Affairs |
| TRADE NAME: | DePuy/Ace MMA Fracture Stem |
| COMMON NAME: | Cemented or Press-Fit Hip Stem |
| CLASSIFICATION: | 888.3353 Hip joint, metal/ceramic/polymersemi-constrained, cemented or nonporousuncemented prosthesis. |
| DEVICE PRODUCT CODE: | 87 LZO |
| SUBSTANTIALLYEQUIVALENT DEVICES: | ♦ DePuy Vision AML Hip Prosthesis♦ DePuy Quantum Hip Stem |
DEVICE DESCRIPTION AND INTENDED USE:
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).
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.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy/Ace MMA Fracture Stem is substantially equivalent to the DePuy Vision Modified Medial Aspect (MMA) AML Prosthesis in that both stems are manufactured from cast Co-Cr-Mo and both have the same basic geometry. The only differences in the designs of these two stems are that the Fracture Stem has distal anterior and posterior
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DePuy/Ace MMA Fracture Stem and the DePuy Vision Standard Triangle AML have approximately the same fatigue strength. The DePuy/Ace MMA Fracture Stem is intended for cemented or press-fit cementless fixation. The DePuy Vision AML is intended for fixation cither with cement or by tissue ingrowth into the porous coating. The DePuy/Ace MMA Fracture Stem is also substantially equivalent to the DePuy Quantum Hip Stem in that both are manufactured from cast Co-Cr-Mo and both have similar designs. The design differences between the Fracture Stern and the Quantum Stem are that the Fracture Stem has distal anterior and posterior grooves, a rounded rather than square lateral shoulder, and a reduced taper diameter and collar size compared to the Quantum Stem. The smallest Fracture Stem has a diameter of 9.0mm whereas the smallest Quantum Stem has a diameter of 10.5mm. Both the Fracture Stem and the Quantum Stem are intended for cemented or press-fit cementless fixation.
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