# K092198: Cormet Cementless Resurfacing Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Apr 15, 2010 after 268 days
- Product code: KXA (Prosthesis, Hip, Femoral, Resurfacing)
- Device class: 2
- Regulation: 21 CFR 888.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K983452 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994153: Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis, Corin USA (2000) Summary page 1.
- K071053: Recap HA Press-Fit Femoral Resurfacing Head, Biomet, Inc. (2007) Summary page 1.

## Indications for use
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 acetzabulum, 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 cementiess use only.

Source page: https://510kreport.com/device/K092198
Methodology: https://510kreport.com/methodology