# K052237: SC Ceramic Ball Heads

- Pathway: 510(k) (Special)
- Applicant: Orthopedic Alliance, LLC
- Decided: Sep 6, 2005 after 20 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: 1 generation back to K031474 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031474: SC Total Hip System, Orthopedic Alliance, LLC (2003) Summary page 1.

## Indications for use
The SC Ceramic Ball Heads are indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-,rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bone cement. The SC Acetabular Cup is for use with bone cement only.

Source page: https://510kreport.com/device/K052237
Methodology: https://510kreport.com/methodology