# K250889: EXULT Knee Replacement System

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: Apr 17, 2025 after 23 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)
- K242046: EXULT Knee Replacement System, Corentec Co., Ltd. (2024) Summary page 5.

## 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. The EXULT Knee Replacement System is intended for cemented use only.

Source page: https://510kreport.com/device/K250889
Methodology: https://510kreport.com/methodology