# K942263: Miller/Galante Precoat Unicompartmental Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jul 11, 1995 after 428 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.
10 later devices descend from it; 4 cite it directly.
0 of 11 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
- K161592: Persona Partial Knee System (2016), 5 descendants of its own
- K212870: TLC Unicompartmental Knee System (2022), 2 descendants of its own
- K081293: Univation Unicondylar Knee System (2008), 1 descendant of its own
- K261609: Freedom Partial Knee System (2026), 0 descendants of its own
- K251771: Cambridge Partial Knee (2025), 0 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/K942263
Methodology: https://510kreport.com/methodology