(25 days)
The PROFEMUR® S 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, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
The design features of the PROFEMUR® S Hip Stem are summarized below:
- Offered in two medial flare options .
- Modular neck taper .
- Triplanar proximal geometry w/ plasma spray .
- Splined, slotted, and cylindrical distal stem w/ grit blast .
- Dimple with cross slot on lateral shoulder ●
- Polished distal tip and collar .
The provided text does not contain any information regarding specific acceptance criteria or a study that evaluates the performance of the PROFEMUR® S Hip Stem against such criteria.
The document is a 510(k) Summary of Safety and Effectiveness for the PROFEMUR® S Hip Stem, which is focused on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device, rather than providing a performance study with specific acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on:
- Intended Use: What the device is designed for.
- Device Description: Its features.
- Substantial Equivalence Information: Comparing it to existing devices to show it's fundamentally similar in design, materials, and technology.
There is no mention of a performance study, acceptance criteria, sample sizes, expert review, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for any test or training sets.
§ 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with a cemented 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. This generic type of device is limited to those prostheses intended for use with 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 a cemented 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 a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.