# K242046: EXULT Knee Replacement System

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: Aug 1, 2024 after 20 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K870730 (1987). 37 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192507: LOSPA II Knee System, Corentec Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K250889: EXULT Knee Replacement System (2025), 0 descendants of its own
- K242401: EXULT Knee Replacement System (2024), 0 descendants of its own

## Indications for use
EXULT Knee Replacement System is indicated for the treatment of diseases as follows: • Painful, disabling joint disease of the knee resulting from non-inflammatory 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 arthroplasty procedure. EXULT Knee Replacement System is intended for cemented application only.

Source page: https://510kreport.com/device/K242046
Methodology: https://510kreport.com/methodology