# K010685: Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular Surface)

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Apr 2, 2001 after 25 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
149 later devices descend from it; 5 cite it directly.
0 of 150 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
- K033363: Zimmer Unicompartmental Knee System (2004), 144 descendants of its own
- K043570: Unicondylar Knee Repair System / Conformis Ucd (2005), 62 descendants of its own
- K080368: Mako Surgical Corp. Unicondylar Knee Implant System II (2008), 56 descendants of its own
- K082172: Mako Modular Knee Compartmental Implant System (2008), 51 descendants of its own
- K090763: Restoris Multicompartmental Knee (MCK) System (2009), 50 descendants of its own

Source page: https://510kreport.com/device/K010685
Methodology: https://510kreport.com/methodology