# K023375: Modification to Esop CO-CR Femoral Heads

- Pathway: 510(k) (Special)
- Applicant: Pro-Active Healthcare
- Decided: Oct 25, 2002 after 17 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K021673 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021673: Total Hip Femoral Head - 12/14 Taper, Smith & Nephew, Inc. (2002)

## Cited in the summary but kept off the family tree
- K021109: Esop CO-CR Femoral Heads, Fournitures Hospitalieres (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The ESOP®Co-Cr Femoral Heads are intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.

Source page: https://510kreport.com/device/K023375
Methodology: https://510kreport.com/methodology