# K963885: Ultima FX Femoral Hip Stems

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Dec 9, 1996 after 74 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Biomet Hip Fracture System: named in the summary without a submission number
- (no number) Biomet Bi-Metric Hip System — Collarless: named in the summary without a submission number
- (no number) Biomet APF Series Modular APF (Anatomical Press Fit): named in the summary without a submission number
- (no number) Zimmer VerSys™ Hip System: named in the summary without a submission number
- (no number) Wright McCutchen Hip Stem: named in the summary without a submission number
- (no number) Wright Nexus™ Hip Stem: named in the summary without a submission number
- (no number) Wright Resolution™ Microtextured Femoral Stem: named in the summary without a submission number
- (no number) Howmedica PercisionOsteolock™ Hip System: named in the summary without a submission number
- (no number) Osteonics Omnifit® Normalized Stem — Collarless: named in the summary without a submission number

## Most influential descendants
- K982812: G2 Total Hip System Femoral Stem (11/13 Taper) (1998), 0 descendants of its own

## Indications for use
The ULTIMA Fx Femoral Hip Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

Source page: https://510kreport.com/device/K963885
Methodology: https://510kreport.com/methodology