# K971681: SMC Femoral Hip Component

- Pathway: 510(k) (Traditional)
- Applicant: Signal Medical Corp.
- Decided: Dec 4, 1997 after 212 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 K852198 (1985). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852198: Aml Proximal Porocoat Femoral Hip, Depuy, Inc. (1985) Summary page 1.
- K962769: Horizon Hip System, Biologically Oriented Prostheses (1996) Summary page 1.

## Most influential descendants
- K981302: SMC 28MM Ceramic Femoral Heads (1998), 0 descendants of its own

## Indications for use
Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Where the use of a more conservative procedure has failed or is unacceptable

Source page: https://510kreport.com/device/K971681
Methodology: https://510kreport.com/methodology