# K222278: LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: Aug 26, 2022 after 28 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.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160157: LOSPA Modular Knee System, Corentec Co., Ltd. (2016) Summary page 5.
- K192507: LOSPA II Knee System, Corentec Co., Ltd. (2019) Summary page 5.
- K110404: Eaum Total Knee System, Corentec Co., Ltd. (2012) Summary page 5.

## Indications for use
LOSPA TKR System is intended for use in total knee arthroplasty surgery for the following indications: • 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. LOSPA TKR System is intended for cemented application only. EXULT Knee 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 System is intended for cemented application only.

Source page: https://510kreport.com/device/K222278
Methodology: https://510kreport.com/methodology