(29 days)
The PROFEMUR® LX Revision 5/8 Coated Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
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- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
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- inflammatory degenerative ioint disease such as rheumatoid arthritis;
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- correction of functional deformity; and,
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- revision procedures where other treatments or devices have failed
The PROFEMUR® L.X Revision 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.
The design features of the PROFEMUR® LX Revision 5/8 Coated Hip Stem are summarized below:
- Manufactured from titanium alloy (Ti6Al4V) .
- Proximal 5/8 of stem plasma sprayed .
- Offered in Sizes 13-21
- Polished distal tip and collar
- Threaded hole with slot impaction mechanism
The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it is a 510(k) summary for a hip stem device, focusing on its intended use, design features, and substantial equivalence to previously cleared predicate devices.
The document states: "The safety and effectiveness of the PROFEMUR® LX Revision 5/8 Coated Hip Stem is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."
However, it does not explicitly detail:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for certain medical devices, rather than presenting a performance study with detailed acceptance criteria and results for the PROFEMUR® LX Revision 5/8 Coated Hip Stem itself.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.