# K121037: Lospa Tibial Base Plate

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: May 3, 2012 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: 5 generations back to K870730 (1987). 15 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 26 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 1.
- K030978: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2003) Summary page 2.

## Most influential descendants
- K130673: Lospa Total Knee Replacement System (2013), 9 descendants of its own
- 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

## Indications for use
The intended use of the modified device [LOSPA Tibial Base Plate] has not changed as a result of the modification of the predicate device cleared under Lospa Total Knee System, K110404. The LOSPA Tibial Base Plate which is a component of Lospa Total Knee 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. The LOSPA Tibial Base Plate is intended for cemented use only.

Source page: https://510kreport.com/device/K121037
Methodology: https://510kreport.com/methodology