# K994153: Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Feb 25, 2000 after 79 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
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K043542: Biopro Tara Femoral Resurfacing Component (2005), 1 descendant of its own
- K092198: Cormet Cementless Resurfacing Femoral Head (2010), 0 descendants of its own
- K070292: Durom Hip Resurfacing System, Femoral Components (2007), 0 descendants of its own
- K021549: Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing System (2002), 0 descendants of its own

## Indications for use
Relief of pain and disability, and restoration of 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. This prosthesis is also intended for patients having deformities of the hip that do not lend themselves to conventional total hip replacement such as previously failed femoral osteotomy, previous fracture, or early deformities of the proximal end of the femur. These make it anatomically impossible to use a conventional femoral component. As above the acetabulum should be essentially normal.

Source page: https://510kreport.com/device/K994153
Methodology: https://510kreport.com/methodology