(204 days)
The DePuy Proximal Femoral Replacement Prosthesis is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty for replacing the hip joint in the following indications, as appropriate: 1) a severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis, 2) avascular necrosis of the femoral head, 3) acute traumatic fracture of the femoral head or neck, 4) failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement, and 5) certain cases of ankylosis.
The DePuy Proximal Femoral Replacement Prosthesis is indicated for uncemented and cemented use as the femoral component in total hip arthroplasty for replacing the hip joint in the following indications, as appropriate: 1) a severely painful and/or a severely disabled joint resulting from osteoarthritis, or theumatoid arthritis, 2) avascular necrosis of the femoral head, 3) acute traumatic fracture of the femoral head or neck, 4) failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement, and 5) certain cases of ankylosis. It is a porous coated (except for the tapered distal tip), straight, cast Co-Cr-Mo stem available in three femoral sizes. The stem has a driving platform, a self-locking 12/14, 0540" taper for attachment of interchangeable modular femoral heads.
This 510(k) premarket notification is for the DePuy Proximal Femoral Replacement Prosthesis, a hip prosthesis.
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1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that this 510(k) summary does not present acceptance criteria or quantitative performance data in the way you might expect for a modern AI/device study. The basis of clearance for this device in 1997 is substantial equivalence to previously cleared predicate devices, not performance against predefined acceptance criteria. Therefore, the "acceptance criteria" here are implicitly the characteristics and intended use of the legally marketed predicate devices.
| Acceptance Criteria (Implicit from Predicate Devices) | Reported Device Performance (Characteristics of DePuy PFR Prosthesis) |
|---|---|
| Intended Use: |
- Femoral component in total hip arthroplasty
- Replacing hip joint for: osteoarthritis, rheumatoid arthritis, avascular necrosis, traumatic fracture, failed previous surgery, ankylosis | Intended Use:
- Femoral component in total hip arthroplasty
- Replacing hip joint for: osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis of femoral head, acute traumatic fracture of femoral head or neck, failed previous surgery (joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, other total hip replacement), certain cases of ankylosis.
- Uncemented and cemented use (similar to Solution Hip Prosthesis). |
| Material: - Co-Cr-Mo alloy (for Porocoat Proximal Femoral Third Prosthesis and Solution Hip Prosthesis) or Ti-6Al-4V (for Proximal Femur Replacement Stem). | Material:
- Cast Co-Cr-Mo stem (identical to Porocoat Proximal Femoral Third Prosthesis and Solution Hip Prosthesis). |
| Porous Coating Placement: - Various placements on predicate devices (e.g., total stem except distal tip, distal stem, entire stem). | Porous Coating Placement:
- Porous coated (except for the tapered distal tip) - identical to Solution Hip Prosthesis. |
| Distal Tip Design: - "Bullet" tapered (Porocoat Proximal Femoral Third, Solution Hip) or "rounded" non-tapered (Proximal Femur Replacement Stem). | Distal Tip Design:
- "Bullet" tapered distal tip (similar to Porocoat Proximal Femoral Third and Solution Hip Prosthesis). |
| Collar/Stem Feature: - Collarless, mid-stem "step", or collar. | Collar/Stem Feature:
- Collarless (similar to Proximal Femur Replacement Stem). |
| Modularity: - Designed to accept modular femoral heads or non-modular. | Modularity:
- Designed to accept modular femoral heads (similar to Proximal Femur Replacement Stem and Solution Hip Prosthesis). Specifically, self-locking 12/14, 0540" taper for attachment of interchangeable modular femoral heads. |
| General Design: - Basic design (e.g., 12/14 taper) (of Proximal Femur Replacement Stem). | General Design:
- Basic design with a 12/14 taper (unchanged from Proximal Femur Replacement Stem cleared in 1990). |
| Manufacturing Process: | Manufacturing Process: - Unchanged from Proximal Femur Replacement Stem cleared by FDA in 1990. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a 510(k) submission based on substantial equivalence, primarily comparing design and material specifications to predicate devices. There is no mention of a "test set" in the context of clinical performance data in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Substantial equivalence claims typically do not involve establishing ground truth from a test set with expert adjudicators. The "ground truth" for the clearance is essentially the regulatory status and established safety/effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical hip prosthesis, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI device.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) clearance is the established safety and effectiveness of the legally marketed predicate devices, as determined by the FDA. The submission demonstrates that the new device is "substantially equivalent" to these predicates.
8. The Sample Size for the Training Set
Not applicable. There is no training set involved as this is a physical medical device clearance based on substantial equivalence to existing products, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is mentioned in this submission.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.