# K192507: LOSPA II Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Dec 11, 2019 after 90 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: 7 generations back to K870730 (1987). 36 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 44 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.
- K121037: Lospa Tibial Base Plate, 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.
- K101433: Depuy Attune Knee System, DePuy Orthopaedics, Inc. (2010) Summary page 6.

## Most influential descendants
- K242046: EXULT Knee Replacement System (2024), 2 descendants of its own
- K200395: LOSPA II Knee System (EXULT Knee Replacement System) (2020), 2 descendants of its own
- K250889: EXULT Knee Replacement System (2025), 0 descendants of its own
- K242401: EXULT Knee Replacement System (2024), 0 descendants of its own
- K222278: LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation (2022), 0 descendants of its own

## Indications for use
LOSPA II 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. LOSPA II Knee System is intended for cemented application only.

Source page: https://510kreport.com/device/K192507
Methodology: https://510kreport.com/methodology