# K934353: Zirconium Alloy Uni-Polar Head

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Apr 25, 1994 after 229 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- 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.
17 later devices descend from it; 3 cite it directly.
0 of 18 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
- 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
- K102370: R3 Xlpe Anteverted Liners (2011), 6 descendants of its own
- K191002: OR3O Dual Mobility System (2019), 5 descendants of its own

Source page: https://510kreport.com/device/K934353
Methodology: https://510kreport.com/methodology