# K990523: B2C, Espace Revision Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Turnkey Intergration USA, Inc.
- Decided: Apr 30, 1999 after 70 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Groupe Lepine B2C Espace, revision acetabular cup system is intended to be used as the pelvic component of a total hip arthoplasty. The acetabular component geometry has been designed to fill large acetabular defects in the floor and superior aspects of the acetabular cavity. It can be implanted either as a press fit cup with bone screw fixation or cemented into the cavity.

Source page: https://510kreport.com/device/K990523
Methodology: https://510kreport.com/methodology