# K973307: S-Rom Zirconia Ceramic Femoral Hip Head

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Nov 20, 1997 after 78 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933275 (1994). 3 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962248: P.F.C. Ceramic Hip Head, Johnson & Johnson Professionals, Inc. (1996) Summary page 1.
- K933275: P.F.C. Ceramic Hip Head, Johnson & Johnson Orthopaedics, Inc. (1994) Summary page 1.
- K921111: S-Rom Zirconia Cermamic Femoral Head, Joint Medical Products Corp. (1992) Summary page 1.

## Most influential descendants
- K980081: S-Rom Zirconia Ceramic Femoral Hip Head (1998), 10 descendants of its own
- K990261: Plus Ceramic Head Prostheses (Alumina and Zirkonia) (1999), 9 descendants of its own
- K012918: Apex Modular Alumina Femoral Head (2001), 7 descendants of its own
- K101451: Apex Module Hip System Biolox Delta Femoral Head (2010), 4 descendants of its own
- K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (2021), 2 descendants of its own

## Indications for use
The S-ROM Zirconia Ceramic Femoral Head 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, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.

Source page: https://510kreport.com/device/K973307
Methodology: https://510kreport.com/methodology