# K980801: J-FX Bipolar Head

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: May 29, 1998 after 88 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- 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 K931655 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945793: P.F.C.(R) Bipolar Hip System - 22MM Bipolar, Johnson & Johnson Professionals, Inc. (1995) Summary page 1.
- K931655: P.F.C. Bipolar Hip System, Johnson & Johnson Orthopaedics, Inc. (1994) Summary page 1.

## Indications for use
The J-FX Bipolar Head is indicated for use in partial hip replacement procedures for patients suffering severe pain and disability due to: femoral fracture avascular necrosis of the femoral head osteoarthritis other abnormalities: — where the major pathology affects the femoral head, — where the acetabular cavity is normal and not deformed or weakened, and — where acetabular replacement is not required or desirable.

Source page: https://510kreport.com/device/K980801
Methodology: https://510kreport.com/methodology