# K981302: SMC 28MM Ceramic Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Signal Medical Corp.
- Decided: Jun 25, 1998 after 77 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 K852198 (1985). 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)
- K971681: SMC Femoral Hip Component, Signal Medical Corp. (1997) Summary page 1.

## 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/K981302
Methodology: https://510kreport.com/methodology