# K021109: Esop CO-CR Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres
- Decided: Jun 12, 2002 after 68 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: 3 generations back to K881288 (1988). 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)
- K953977: Primaloc Cementless Hip System, Ortho Development Corp. (1996) Summary page 1.
- K923911: Intrinsic Stem, Turnkey Intergration USA, Inc. (1993) Summary page 1.
- K010081: Acumatch L-Series Unipolar Endoprosthesis, Exactech, Inc. (2001)
- (no number) Headloc Femoral Head: named in the summary without a submission number

## Most influential descendants
- K050556: Alumina Head (2005), 0 descendants of its own

## 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/K021109
Methodology: https://510kreport.com/methodology