# K200395: LOSPA II Knee System (EXULT Knee Replacement System)

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: May 7, 2020 after 79 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: 12 generations back to K943462 (1994). 116 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192507: LOSPA II Knee System, Corentec Co., Ltd. (2019) Summary page 4.
- K130673: Lospa Total Knee Replacement System, Corentec Co., Ltd. (2013) Summary page 5.
- K110404: Eaum Total Knee System, Corentec Co., Ltd. (2012) Summary page 5.
- K121037: Lospa Tibial Base Plate, Corentec Co., Ltd. (2012) Summary page 6.
- K160157: LOSPA Modular Knee System, Corentec Co., Ltd. (2016) Summary page 5.
- K190402: Triathlon Total Knee System-Additional Components, Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) (2019) Summary page 6.
- K173849: Triathlon Total Knee System, Stryker Orthopaedics (2018) Summary page 6.
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, Stryker Orthopaedics (2017) Summary page 6.
- K042343: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2005) Summary page 6.
- K071991: Modification to Scorpio NRG Knee System, Howmedica Osteonics Corp. (2007) Summary page 6.

## Most influential descendants
- K212034: LOSPA TKR System (2021), 0 descendants of its own
- K201851: EXULT Femoral component trial - Left, EXULT Femoral component trial - Right (2020), 0 descendants of its own

## Indications for use
LOSPA II Knee System (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. LOSPA II Knee System (EXULT Knee Replacement System) is intended for cemented application only.

Source page: https://510kreport.com/device/K200395
Methodology: https://510kreport.com/methodology