(199 days)
The Foundation® Press-Fit Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. It is intended to be used press-fit.
The proximal body is trapezoidal in cross-sectional geometry. The distal stem portion is conical in shape and has flutes to provide rotational stability. A coronal slot in the larger stems decreases implant stiffness.
The stem is available with and without a calcar collar and has a Morse type taper to receive modular heads. The neck/stem angle is 132°.
The Foundation® Press-Fit Hip Stem is fabricated from wrought/forged Ti-6AI-4V. The proximal body of the stem has a plasma sprayed surface to enhance press-fit fixation.
This document does not contain the information requested about acceptance criteria or a study proving device performance. The provided text is a summary of safety and effectiveness for a medical device called the "Foundation® Press-Fit Hip Stem." It describes the device's characteristics, intended use, and comparable features to predicate devices.
The "Test Results" section only states: "Laboratory testing of the Morse type taper was conducted." This is too vague to extract the specific information requested, such as:
- Acceptance criteria: It doesn't list any specific performance metrics or thresholds.
- Reported device performance: It doesn't provide any quantitative or qualitative results from the testing.
- Study details: There's no information about sample sizes, data provenance, ground truth establishment, expert involvement, or comparative effectiveness.
Therefore, I cannot fulfill your request based on the provided input.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.