Data / Medical devices / Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Assembly, Thigh/Knee/Shank/Ankle/Foot, External (KFX): 10 FDA-registered makers in 5 countries
10 establishments in 5 countries are registered with the FDA to make Assembly, Thigh/Knee/Shank/Ankle/Foot, External (product code KFX, Class 2, 21 CFR 890.3500). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on July 22, 1993, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- KFX
- Device class
- 2
- Regulation
- 890.3500
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 2 |
| India | 1 |
| Egypt | 1 |
| Australia | 1 |
Makers of Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Lemaitre Vascular, Inc. | Burlington, MA, United States | Manufacturer | 1 | July 22, 1993 | 0 | 1 | 0 | api.fda.gov |
| LeMaitre Vascular Inc. | Billerica, MA, United States | Manufacturer | 1 | July 22, 1993 | 0 | 0 | 0 | api.fda.gov |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| BioSkin LLC | Ashland, OR, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Meiguan Care Products Technology Co.,ltd. | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Limber Prosthetics, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miracle Medical Industries | El Obour City Al Qahirah, Egypt | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osseointegration International, Inc. | New York, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osseointegration International Pty Ltd | Macquarie Park New South Wales, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 22, 1993. 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.