# K043542: Biopro Tara Femoral Resurfacing Component

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: May 18, 2005 after 146 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: 3 generations back to K983452 (1998). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032659: Depuy Asr Resurfacing Femoral Heads, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K994153: Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis, Corin USA (2000) Summary page 1.
- K023188: Press-Fit Head Resurfacing Device, Biomet Orthopedics, Inc. (2002) Summary page 1.
- (no number) Wright Medical CONSERVE Femoral Surface Replacement: named in the summary without a submission number

## Most influential descendants
- K070292: Durom Hip Resurfacing System, Femoral Components (2007), 0 descendants of its own

## Indications for use
Indications for use include a severe disabling and/or painful hip associated with the following indications: 1) Osteoarthritis, 2) Traumatic arthritis, 3) Rheumatoid arthritis, 4) Advanced avascular necrosis, 5) Congentital hip dysplasia, and 6) Slipped captial femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

Source page: https://510kreport.com/device/K043542
Methodology: https://510kreport.com/methodology