# K880155: Miller/Galante Precoat Unicompartmental Knee

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Aug 3, 1988 after 203 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
151 later devices descend from it; 5 cite it directly.
0 of 152 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

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1055-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro

Source page: https://510kreport.com/device/K880155
Methodology: https://510kreport.com/methodology