(29 days)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid ● arthritis, or congenital hip dysplasia;
- Avascular necrosis of the femoral head; ●
- Acute traumatic fracture of the femoral head or neck; ●
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, ● hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
- Certain cases of ankylosis. ●
The Summit FX Cemented Hip Stem is intended for cemented use only.
The Summit FX Cemented Hip Stem is a flanged, collared, tapered Cobalt-Chromium femoral stem with a smooth surface finish. The Summit FX Cemented Hip Stem is offered in 7 sizes with a constant offset. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. The stem is designed specifically to treat femoral head and neck fractures but can be used for any of the indications listed below.
The supplied text is a 510(k) premarket notification for the DePuy Summit FX Cemented Hip Prosthesis. This document is for a medical device and describes its intended use and similarity to an already approved device. It does not contain information about studies proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance. The document focuses on demonstrating substantial equivalence to a previously approved device (DePuy Summit Cemented Hip Prosthesis, K013352) rather than presenting new clinical study data.
§ 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.