# K961939: S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Aug 13, 1996 after 85 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: 2 generations back to K935452 (1994). 8 ancestors in all.
210 later devices descend from it; 9 cite it directly.
0 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851422: S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip, Joint Medical Products Corp. (1985) Summary page 1.
- K913231: S-Rom (TM) Total Lhip System W/Ceramic Head, Joint Medical Products Corp. (1991) Summary page 1.
- K921111: S-Rom Zirconia Cermamic Femoral Head, Joint Medical Products Corp. (1992) Summary page 1.
- K934412: Coated ZT Proximal Sleeve, Joint Medical Products Corp. (1994) Summary page 1.
- K910664: Mod. Trochanter Screw & Washer W/ Anodized Titan., Medimix Products, Inc. (1992) Summary page 1.
- K954935: S-Rom Femoral Hip Stem - Size 14 X 8, Joint Medical Products Corp. (1996) Summary page 1.
- K945518: P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component, Johnson & Johnson Professionals, Inc. (1996). Our OCR of the scanned summary read K944518, FDA’s number for Widex Model Logo 8S (Widex Hearing Aid Co., Inc.). Corrected to the only number one digit away that is an earlier device of this one’s maker, Johnson & Johnson Professionals, Inc., in this field.

## Most influential descendants
- K974331: Uni-Rom Total Hip System Femoral Stem (1998), 189 descendants of its own
- 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

## Indications for use
The S-ROM Femoral Hip Stem - Sizes 12 x 06 x 115 and 12 x 07 x 115 is intended for non-cemented fixation as the femoral component of a total hip replacement system. The stems are indicated for use in primary and revision replacement surgery. The prosthesis may be used for the following conditions, as appropriate: . Osteoarthritis; . Traumatic Fractures; o. Rheumatoid Arthritis; . Avascular Necrosis; and . Congenital Dislocation.

Source page: https://510kreport.com/device/K961939
Methodology: https://510kreport.com/methodology