(60 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a hip stem, with no mention of AI or ML.
Yes.
The device is a femoral component used in total hip arthroplasty to replace damaged hip joints, which directly treats a medical condition.
No
The device is a hip implant used for replacement in total hip arthroplasty, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a cast Co-Cr-Mo hip stem, which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided text describes a femoral component (hip stem) used in total hip arthroplasty. This is a surgical implant that is placed inside the patient's body to replace a damaged hip joint.
The device is a physical implant used in surgery, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
87 LZO
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The DePuy/Ace MMA Fracture Stem and the DePuy Vision Standard Triangle AML have approximately the same fatigue strength.
Key Metrics
Not Found
Predicate Device(s)
DePuy Vision AML Hip Prosthesis, DePuy Quantum Hip Stem
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
K964704
SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 2 4 1997
| NAME OF FIRM: | DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Cheryl Hastings
Manager, Clinical Affairs |
| TRADE NAME: | DePuy/Ace MMA Fracture Stem |
| COMMON NAME: | Cemented or Press-Fit Hip Stem |
| CLASSIFICATION: | 888.3353 Hip joint, metal/ceramic/polymer
semi-constrained, cemented or nonporous
uncemented prosthesis. |
| DEVICE PRODUCT CODE: | 87 LZO |
| SUBSTANTIALLY
EQUIVALENT 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
1
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.