Primary
CFDACEFDA
A3 Primary Total Knee System
Internationally approved primary total knee system with PS and PS Plus insert options. 12 femoral sizes, 13 tibial tray sizes, and patella.
Key Facts
- Manufacturer
- AK Medical Holdings Limited (HKEX: 01789.HK)
- Product family
- Knee System
- Component type
- Primary
- Regulatory clearances
- NMPA (China, formerly CFDA); CE Mark (European Union); FDA (United States)
- Femoral Material
- Co-Cr-Mo Alloy
- Insert Material
- UHMWPE
- Tray Sizes
- S, A, B, B+, C, C+, D, D+, E, F, G, H, L (13 sizes)
- Femoral Sizes
- LS1–L7 (Left), RS1–R7 (Right)
- Keywords
- TKA, Knee primary
Description
The A3 Primary Total Knee System is a comprehensive primary knee arthroplasty system with FDA, CE, and CFDA clearances. Features fixed tibial tray design, left and right femoral condylar options, patella component, and multiple tibial insert configurations including PS and PS Plus options. Universal design for broad applicability.
System Components
| Component | Description |
|---|---|
| Femoral Condylar | Left / Right (Co-Cr-Mo Alloy) |
| Fixed Tibial Tray | Universal design |
| Tibial Insert - PS | Posterior Stabilized (UHMWPE) |
| Tibial Insert - PS Plus | Posterior Stabilized Plus (UHMWPE) |
| Patella | UHMWPE |
Materials
| Component | Material |
|---|---|
| Metal Components | Co-Cr-Mo Alloy |
| Inserts & Patella | UHMWPE |
Features
- Triple regulatory clearance: CFDA, CE, and FDA
- Comprehensive primary knee arthroplasty system
- Fixed tibial tray design for reliable fixation
- Left and right femoral condylar options
- PS and PS Plus tibial insert options for varying stability requirements
- Universal design for broad patient population applicability
- UHMWPE patella component included
Regulatory References
- U.S. FDA 510(k) premarket notification K180493 — A3 Total Knee System, Beijing AK Medical Co., Ltd., decision date 22 June 2018. FDA 510(k) database · clearance letter (PDF)
Surgical Technique Videos
Regulatory status and availability vary by market. Product information is provided for healthcare professionals and is not medical advice; refer to the instructions for use and surgical technique for each device.
Request the A3 Primary Total Knee System datasheet
Surgical technique, full sizing and distribution enquiries.
