(88 days)
The CONSERVE® Pressfit Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.
CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use
The design features of the CONSERVE® Femoral Resurfacing Component are summarized below:
- Manufactured from Cobalt Chrome Alloy
- 12 Sizes in 2mm increments
- Plasma Spray undersurface
This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it describes a substantial equivalence determination for a medical device.
Therefore, I cannot fulfill your request as the required information is not present in the provided text.
§ 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.