# K896580: Uni-Polar Head

- Pathway: 510(k) (Traditional)
- Applicant: Richards Medical Co., Inc.
- Decided: Feb 15, 1990 after 90 days
- Product code: LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 8 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K061243: Smith & Nephew Modular Femoral Head (2006), 19 descendants of its own
- K062408: Smith & Nephew Modular Femoral (Hemi) Head (2006), 18 descendants of its own
- K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners (2010), 16 descendants of its own
- K113848: R3 Xlpe Liners (2012), 7 descendants of its own
- K161233: OXINIUM DH Fermoral Heads (2016), 6 descendants of its own

Source page: https://510kreport.com/device/K896580
Methodology: https://510kreport.com/methodology