(88 days)
The Foundation® Fracture Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, theumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used in a press fit mode.
The femoral stem is straight. The proximal body is trapezoidal in cross-sectional geomety. A Morse type taper is used to receive modular heads. The neck/stem angle is 132. The Foundation® Fracture Stem is fabricated from wrought/forged Ti-6A1-4V. The entire stem is grit blasted. The stem is available in six sizes.
The provided text is a 510(k) submission summary for a medical device called the Foundation® Fracture Stem. It details its description, intended use, and comparison to predicate devices. However, it does not contain any information about acceptance criteria, device performance, sample sizes for testing, expert involvement, adjudication methods, or specific study designs (like MRMC or standalone performance).
The "Test Results" section only states: "Testing on this device included fatigue testing on the Morse type taper." This is a very general statement and does not provide any specific criteria or quantitative results.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about the studies mentioned in sections 2-9, as this information is not present in the provided document.
To answer your request, I would need a document that explicitly details the performance metrics, acceptance thresholds, and the results of specific studies conducted to demonstrate the device's efficacy and safety.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.