Data / Medical devices / Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer / China
FDA-registered makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer in China: 18 establishments
18 establishments in China are registered with the FDA to make Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (product code JWH). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Product code
- JWH
- Country
- China
Makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Depuy Synthes (suzhou) Medical Devices Co., Ltd. | SUZHOU Jiangsu, China | Manufacturer | 15 | August 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou City Jiangsu, China | Contract manufacturer, Manufacturer | 9 | July 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua Zhejiang, China | Contract manufacturer, Manufacturer | 6 | December 23, 2014 | 0 | 0 | 0 | api.fda.gov |
| Beijing Ak Medical Co, Ltd | Changping District Beijing, China | Complaint file establishment, Manufacturer, Specification developer | 1 | June 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Beijing Ikey Medical Device Technology Co., Ltd. | Beijing, China | Manufacturer | 1 | April 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Aquila Precise Tools Limited | Guangzhou City Guangdong, China | Contract manufacturer, Manufacturer | 1 | November 9, 2012 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | February 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan Jiangsu, China | Contract manufacturer, Manufacturer | 1 | October 27, 2015 | 0 | 0 | 0 | api.fda.gov |
| B-One Medical (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canwell Medical Co., Ltd. | Jinhua Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LX Precision Shanghai Co Ltd | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker (Suzhou) Medical Technology Co.,Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou, Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yu Xin Technology(huizhou) Co.,ltd | HuiZhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.