# K943586: Zirconia Ceramic Modular Heads (Astro Met)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 17, 1994 after 87 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
No predicates in its family tree.
346 later devices descend from it; 1 cites it directly.
0 of 347 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
- K042091: Biolox Delta Ceramic Heads (2005), 345 descendants of its own
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads (2005), 344 descendants of its own
- K061312: 36MM Biolox Delta Ceramic Heads (2006), 343 descendants of its own
- K071535: Biolox Delta Ceramic Femoral Head (2007), 217 descendants of its own
- K082844: Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve (2008), 165 descendants of its own

Source page: https://510kreport.com/device/K943586
Methodology: https://510kreport.com/methodology