# K033769: Eius Unicompartmental Knee System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 13, 2004 after 72 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
Longest line of descent: 1 generation back to K923011 (1993). 4 ancestors in all.
121 later devices descend from it; 7 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992287: First Step Unicompartmental Knee System, Howmedica Osteonics Corp. (1999) Summary page 1.
- K962152: Osteonics Scorpio Posteriorly Stabilized Total Knee System, Osteonics Corp. (1996) Summary page 1.
- K923011: Osteonics Unix Unicompartmental, Osteonics Corp. (1993) Summary page 1.
- K980665: Repicci II Unicondylar Knee All Poly Tibial Components, Biomet, Inc. (1998) 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

## Indications for use
The EIUS ® Knee System components are for use in Unicompartmental knee arthroplasty as a result of: * Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis * Revision of previous unsuccessful unicompartmental knee replacement or other procedure * As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis These components are single use only and are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K033769
Methodology: https://510kreport.com/methodology