(86 days)
The PROFEMUR® TL 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:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; and, 3.
- revision procedures where other treatments or devices have failed 4.
The design features of the PROFEMUR® TL Hip Stem are summarized below:
- Wrought or forged titanium alloy (ASTM F136 or F620) .
- Body shape is a flat tapered wedge .
- Cross-section is rectangular with radiussed medial and lateral sides .
- Size range 1-12 .
- Glass bead surface finish, with proximal plasma spray coating .
- Neck taper for use with modular necks .
- Dimple and cross slot impaction mechanism .
This is a 510(k) premarket notification for a medical device called the PROFEMUR® TL Hip Stem, a hip implant. The document states that the device is substantially equivalent to predicate devices, and therefore does not require the extensive clinical trials and performance studies typical of novel medical AI devices.
As such, none of the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details) are present in the provided text. The document focuses on demonstrating substantial equivalence to existing devices rather than presenting novel performance data.
The FDA's letter (pages 2-3) confirms the "substantial equivalence determination" to a "legally marketed predicate device," which is a regulatory pathway that bypasses the need for new clinical effectiveness data if the device is similar enough to one already on the market.
§ 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.