# K033363: Zimmer Unicompartmental Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jan 16, 2004 after 87 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K880155 (1988). 2 ancestors in all.
144 later devices descend from it; 22 cite it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880155: Miller/Galante Precoat Unicompartmental Knee, Zimmer, Inc. (1988) Summary page 1.
- K010685: Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular Surface), Zimmer, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K052687: Conformis, Inc. Total Knee Repair System (2006), 43 descendants of its own

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1054-2018: 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
- Jan 11, 2016 · Class II · Z-0836-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- Aug 30, 2013 · Class II · Z-0076-2014: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

## Indications for use
These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. These devices are indicated for cemented use only. The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Source page: https://510kreport.com/device/K033363
Methodology: https://510kreport.com/methodology