# K965198: Ultima TPS Cemented Stem

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson International
- Decided: Jul 23, 1997 after 209 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- 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 K891454 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891454: Exeter II Total Hip System, Howmedica Corp. (1989) Summary page 1.
- (no number) Zimmer CPT hip stem: named in the summary without a submission number

## Indications for use
The ULTIMA* TPS Cemented 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, nonunion of femoral fractures, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion where bone stock is inadequate for other reconstruction techniques. The ULTIMA* TPS Cemented Stem is indicated for use only with PMMA bone cement.

Source page: https://510kreport.com/device/K965198
Methodology: https://510kreport.com/methodology