# K160157: LOSPA Modular Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Dec 1, 2016 after 314 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915192 (1992). 7 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces, Zimmer, Inc. (1996) Summary page 8.
- K994128: Scorpio Total Stablizer (TS) Total Knee System, Howmedica Osteonics Corp. (2000) Summary page 8.

## Most influential descendants
- K192507: LOSPA II Knee System (2019), 7 descendants of its own
- 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

## Recalls of this device
- Mar 29, 2024 · Class II · Z-1934-2024: Due to unsupported 10 year expiration date.
- Mar 29, 2024 · Class II · Z-1935-2024: Due to unsupported 10 year expiration date.

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

Source page: https://510kreport.com/device/K160157
Methodology: https://510kreport.com/methodology