# K964795: Cemented Calcar Replacement Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Feb 19, 1997 after 82 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
Longest line of descent: 1 generation back to K902712 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922503: Howmedica (R) HNR System, Howmedica Corp. (1992) Summary page 1.
- K902712: Osteonics PS Head and Neck Hip Stem Series, Osteonics Corp. (1990) Summary page 1.
- K952859: Ultima Cemented Long Stem Femoral Component, Johnson & Johnson Professionals, Inc. (1996) Summary page 1.

## Indications for use
The Ultima Total Hip System - Cemented Calcar Replacement Femoral Stem is indicated for use in total, partial, or revision hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint form rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic femoral fractures, and nonunion of femoral fractures. Use of the prothesis is also indicated for patients with congenital hip dysplasia, profrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques. The Ultima Cemented Calcar Replacement Stem is indicated for use only with PMMA bone cement.

Source page: https://510kreport.com/device/K964795
Methodology: https://510kreport.com/methodology