Data / Medical devices / Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees (PJY): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees (product code PJY, Class 3). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PJY
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| Sweden | 4 |
| United States | 2 |
| Germany | 1 |
Makers of Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
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 |
|---|---|---|---|---|---|---|---|---|
| Integrum AB | Molndal Vastra Gotaland, Sweden | Exporter to the US, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Alm Ortho, Inc. | Scarborough, ME, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| BBF Sterilisationsservice GMBH | Kernen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laser Nova AB | Ostersund Jamtland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Part Precision Sweden AB | Mariestad Vastra Gotaland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Willo AB | Vaxjo Kronoberg, Sweden | 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.