# K180493: A3 Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing AK Medical Co., Ltd.
- Decided: Jun 22, 2018 after 116 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 K810258 (1981). 42 ancestors in all.
1 later device descends from it; 1 cites 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)
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012) Summary page 4.
- K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 4.

## Most influential descendants
- K230120: KeYi Total Knee System (2024), 0 descendants of its own

## Indications for use
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 A3 Total Knee System is indicated for cemented use only.

Source page: https://510kreport.com/device/K180493
Methodology: https://510kreport.com/methodology