# K974331: Uni-Rom Total Hip System Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Feb 6, 1998 after 80 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K935452 (1994). 9 ancestors in all.
189 later devices descend from it; 1 cites it directly.
0 of 199 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961939: S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115), Johnson & Johnson Professionals, Inc. (1996) Summary page 1.
- K954935: S-Rom Femoral Hip Stem - Size 14 X 8, Joint Medical Products Corp. (1996) Summary page 1.
- K851422: S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip, Joint Medical Products Corp. (1985) Summary page 1.
- K945518: P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component, Johnson & Johnson Professionals, Inc. (1996) Summary page 1.
- K935452: P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component, Johnson & Johnson Orthopaedics, Inc. (1994) Summary page 1.

## Most influential descendants
- K001991: Titan Porocoat Hip Prosthesis (2000), 188 descendants of its own
- K042992: Corail Amt Hip Prosthesis (2005), 168 descendants of its own
- K082525: Corin Metafix Femoral Stem (2010), 71 descendants of its own
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty (2012), 61 descendants of its own
- K070554: Depuy Corail Amt Dysplasia Hip Prosthesis (2007), 49 descendants of its own

## Indications for use
The UNI-ROM™ Total Hip System Femoral Stem is indicated for use in total 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, and nonunion 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 reconstructive techniques.

Source page: https://510kreport.com/device/K974331
Methodology: https://510kreport.com/methodology