# K964878: Esop S/C Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres
- Decided: Mar 5, 1998 after 455 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: 1 generation back to K923911 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- K021108: Esop HA Femoral Stem (2002), 0 descendants of its own

## Indications for use
The ESOP® S/C Femoral Stem is a device 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 exists sufficient sound bone to seat the prosthesis. This device is intended for cementless application.

Source page: https://510kreport.com/device/K964878
Methodology: https://510kreport.com/methodology