# K110404: Eaum Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Feb 16, 2012 after 367 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K870730 (1987). 14 ancestors in all.
14 later devices descend from it; 8 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060515: Depuy PFC Sigma Knee Prosthesis, DePuy Orthopaedics, Inc. (2006) Summary page 2.
- K053514: Triathlon Total Knee System, Stryker Orthopaedics (2006) Summary page 2.
- K030978: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2003) Summary page 2.

## Most influential descendants
- K121037: Lospa Tibial Base Plate (2012), 10 descendants of its own
- K130673: Lospa Total Knee Replacement System (2013), 9 descendants of its own
- K192507: LOSPA II Knee System (2019), 7 descendants of its own
- K170753: Acculoc Total Knee System (2018), 3 descendants of its own
- K242046: EXULT Knee Replacement System (2024), 2 descendants of its own

## Recalls of this device
- Mar 29, 2024 · Class II · Z-1934-2024: Due to unsupported 10 year expiration date.
- Mar 29, 2024 · Class II · Z-1935-2024: Due to unsupported 10 year expiration date.

## Indications for use
The EAUM Total Knee System is intended for use in total knee arthroplasty surgery for the following indications:* Painful, disabling joint disease of the knee resulting from noninflamimatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis; Post-traumatic loss of knee joint configuration and function; Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthropiasty procedure. The EAUM Total Knee System is intended for cemented use only.

Source page: https://510kreport.com/device/K110404
Methodology: https://510kreport.com/methodology