# K021549: Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing System

- Pathway: 510(k) (Traditional)
- Applicant: Std Mfg., Inc.
- Decided: Aug 1, 2002 after 80 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: 1 generation back to K983452 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 3.
- K983452: Nelson Resurfacing Head, Biomet, Inc. (1998) Summary page 4.

## 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, with the bearing surface and supportive bone structure of the acetabulum being normal. The device is a single use implant intended to be used for cemented, hemi-hip, resurfacing applications only.

Source page: https://510kreport.com/device/K021549
Methodology: https://510kreport.com/methodology