# K965019: The C-Fit Femoral Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Mar 25, 1997 after 99 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. The FDA summary names its predicate without a number.
- (no number) V.S.P. (now called C-Fit stem) Hip system: named in the summary without a submission number
- (no number) Mallory/head system from Biomet: named in the summary without a submission number

## Indications for use
The devices are used to resurface the femoral hip joint and reconstitute function following the degenerative effects of osteo and rheumatoid arthritis, post trauma disease effects, avascular necrosis and septic or aseptic total hip revision.

Source page: https://510kreport.com/device/K965019
Methodology: https://510kreport.com/methodology