# K242401: EXULT Knee Replacement System

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: Sep 12, 2024 after 30 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: 9 generations back to K870730 (1987). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 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.
- K242046: EXULT Knee Replacement System, Corentec Co., Ltd. (2024) Summary page 5.

## Indications for use
EXULT Knee Replacement System is intended 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/K242401
Methodology: https://510kreport.com/methodology