# K230120: KeYi Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Keyi Medical Device Technology Co., Ltd.
- Decided: Apr 19, 2024 after 458 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: 8 generations back to K810258 (1981). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO, Zimmer, Inc. (1999) Summary page 4.
- K180493: A3 Total Knee System, Beijing AK Medical Co., Ltd. (2018) Summary page 4.

## Indications for use
The KeYi Total Knee System indications for use are: • Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis) or rheumatoid arthritis. • Correction of functional deformities. • Post-traumatic loss of knee joint configuration and function. • Moderate valgus, varus, or flexion deformity. • Knee fractures untreatable by other methods. The KeYi Total Knee System is indicated for cemented use only.

Source page: https://510kreport.com/device/K230120
Methodology: https://510kreport.com/methodology