# K212034: LOSPA TKR System

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Dec 9, 2021 after 163 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: 13 generations back to K943462 (1994). 117 ancestors in all.
No later device cites it as a predicate yet.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110404: Eaum Total Knee System, Corentec Co., Ltd. (2012) Summary page 5.
- K130673: Lospa Total Knee Replacement System, Corentec Co., Ltd. (2013) Summary page 5.
- K160157: LOSPA Modular Knee System, Corentec Co., Ltd. (2016) Summary page 5.
- K192507: LOSPA II Knee System, Corentec Co., Ltd. (2019) Summary page 5.
- K200395: LOSPA II Knee System (EXULT Knee Replacement System), Corentec Co., Ltd. (2020) 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 TRK System is intended for cemented application only.

Source page: https://510kreport.com/device/K212034
Methodology: https://510kreport.com/methodology