(268 days)
The Cormet Cementless Resurfacing Femoral Head is indicated for hemi hip resurfacing arthroplasty in patients with non-inflammatory degenerative joint disease, including osteo and rheumatoid arthritis, post traumatic disease and avascular necrosis.
It is indicated for relief of pain and disability, and to restore hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, the bearing surface and supportive bone structure of the acetabulum being normal.
It is intended for patients having deformities of the hip that do not lend themselves to conventional total hip replacement such as:
- previously failed femoral osteotomy, .
- early deformities of the proximal end of the femur. .
The Cormet Cementless Resurfacing Femoral Head is indicated for cementless use only.
The Cormet Cementless Resurfacing Femoral Head is a femoral component manufactured from cast cobalt-chromium-molybdenum (Co-Cr-Mo) alloy complying with the requirements of ASTM F75 and ISO 5832-4. It is designed to replace the outer surface of the natural femoral head for hemi hip arthroplasty and articulates against the natural acetabulum. The component has a central stem and three internal splines to provide anti-rotational stability. The inner, bone contacting surfaces of the component have coatings of plasma sprayed titanium and hydroxyapatite for cementless fixation. The Cormet Cementless Resurfacing Femoral Head is not approved for use with an acetabular component in the US.
The provided text is a 510(k) summary for a medical device called the "Cormet Cementless Resurfacing Femoral Head." It outlines the device description, intended use, and claims of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets such criteria.
Specifically, the document states:
- "Non-clinical testing submitted to support a determination of substantial equivalence was based on coating characterization. The coating applied to the Cormet Cementless Resurfacing Femoral Head consisting of plasma sprayed titanium and hydroxyapatite was characterized and cleared under K083312 (Corin MiniHip Stem)." (Section 11)
- "No additional bench testing was required since the cemented version of the device is a legally marketed predicate device." (Section 11)
- "Clinical testing was not necessary to determine substantial equivalence between the Cormet Cementless Resurfacing Femoral Head and the predicate devices." (Section 12)
Therefore, based on the provided text, I cannot complete the requested information, as the device's approval was based on substantial equivalence to existing devices and coating characterization, not on a study demonstrating its performance against specific acceptance criteria.
§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing 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 resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.