# K021108: Esop HA Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Fournitures Hospitalieres
- Decided: May 3, 2002 after 28 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923911 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964878: Esop S/C Femoral Stem, Fournitures Hospitalieres (1998) Summary page 1.
- K953111: Corail, Landos, Inc. (1996) Summary page 1.

## Indications for use
The ESOP® HA Femoral Stem is 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/K021108
Methodology: https://510kreport.com/methodology