Data / Medical devices / Prosthesis, Hip, Cement Restrictor
Prosthesis, Hip, Cement Restrictor (JDK): 15 FDA-registered makers in 4 countries
15 establishments in 4 countries are registered with the FDA to make Prosthesis, Hip, Cement Restrictor (product code JDK, Class 2, 21 CFR 878.3300). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 54 510(k) clearances under this code, the latest on April 8, 2021, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JDK
- Device class
- 2
- Regulation
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Switzerland | 2 |
| Germany | 1 |
| Italy | 1 |
Makers of Prosthesis, Hip, Cement Restrictor
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 |
|---|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 5 | October 10, 2001 | 0 | 0 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer | 3 | August 3, 2001 | 0 | 0 | 0 | api.fda.gov |
| Howmedica Osteonics Corp | Mahwah, NJ, United States | Manufacturer | 2 | March 22, 1994 | 0 | 0 | 0 | api.fda.gov |
| Medacta International SA | Castel San Pietro Ticino, Switzerland | Complaint file establishment, Exporter to the US, Manufacturer | 2 | April 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medacta International SA | Rancate Ticino, Switzerland | Complaint file establishment, Exporter to the US, Manufacturer | 2 | April 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| Life Spine | Huntley, IL, United States | Specification developer | 1 | May 11, 2006 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Deggendorf GMBH | DEGGENDORF Bavaria, Germany | Manufacturer | 1 | October 10, 2001 | 0 | 0 | 0 | api.fda.gov |
| Precision Spine, Inc. | Pearl, MS, United States | Manufacturer | 1 | March 16, 2006 | 0 | 0 | 0 | api.fda.gov |
| Tecres SPA | VERONA Veneto, Italy | Manufacturer | 1 | August 16, 2002 | 0 | 0 | 0 | api.fda.gov |
| Ken-Mar Machine MFG Corp | Paterson, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polymer Corporation | Middletown, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Brimfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 8, 2021. 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.