# K992490: B2C Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Lepine Groupe Spa.
- Decided: Aug 19, 1999 after 24 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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 B2C hip stem system is intended to be used as a press fit or cemented femoral hip component as part of a total hip arthoplasty. The stem geometry has been designed to be either implanted with or without cemented into the femoral cavity. The stems are to be used to restore the femoral side of a total joint arthoplasty and is used in conjunction with an acetabular cup. The indications for use of the B2C hip system are as follows: Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies. Salvage of previous unsuccessful procedures such as osteosynthesis, joint reconstruction, arthrodesis, hemi or total hip arthroplasty. Bipolar head or Austin Moore type head revision. Fracture or avascular necrosis of the femoral head in the elderly. Replacement of acetabular and stem component in total hip arthroplasty. Primary arthroplasty of the acetabular in dysplastic hips.

Source page: https://510kreport.com/device/K992490
Methodology: https://510kreport.com/methodology