Data / Medical devices / Prosthesis, Hip, Femoral Component, Cemented, Metal
Prosthesis, Hip, Femoral Component, Cemented, Metal (JDG): 39 FDA-registered makers in 8 countries
39 establishments in 8 countries are registered with the FDA to make Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG, Class 2, 21 CFR 888.3360). 10 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 59 510(k) clearances under this code, the latest on February 7, 2022, and lists 9 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JDG
- Device class
- 2
- Regulation
- 888.3360
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 22 |
| China | 4 |
| Ireland | 3 |
| Germany | 3 |
| Malaysia | 3 |
| United Kingdom | 2 |
| France | 1 |
| Switzerland | 1 |
Makers of Prosthesis, Hip, Femoral Component, Cemented, Metal
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 |
|---|---|---|---|---|---|---|---|---|
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 5 | September 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Howmedica Osteonics Corp | Mahwah, NJ, United States | Manufacturer, Specification developer | 2 | March 19, 2018 | 0 | 3 | 0 | api.fda.gov |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou City Jiangsu, China | Manufacturer | 1 | September 20, 1994 | 0 | 0 | 0 | api.fda.gov |
| Corin Limited | CIRENCESTER Gloucestershire, United Kingdom | Manufacturer | 1 | November 10, 1999 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 1 | September 27, 2000 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 1 | September 27, 2000 | 0 | 0 | 0 | api.fda.gov |
| Howmedica International S. De R.L. | LIMERICK Munster, Ireland | Manufacturer | 1 | March 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Meridian Medical Limited | Littlehampton West Sussex, United Kingdom | Manufacturer, Repackager or relabeler | 1 | November 10, 1999 | 0 | 0 | 0 | api.fda.gov |
| Stryker Ireland Osteonics | County Cork, Ireland | Manufacturer | 1 | March 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Waldemar Link GmbH & Co. KG | Norderstedt Schleswig-Holstein, Germany | Manufacturer | 1 | November 6, 1995 | 0 | 2 | 0 | api.fda.gov |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | 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 | |
| Encore Medical, L.P. | Austin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marson Medical, Inc. | Paramus, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Medical LLC | Memphis, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perryman Company | Houston, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precera Medical Herouville SAS | HEROUVILLE ST CLAIR CEDEX Normandie, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puracon GMBH | Rosenheim Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SCT, Inc. | Franklin Lakes, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Orthopaedics AG | AARAU Aargau, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical, Inc. - Manchester | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Anngrove | Cork Munster, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turnco Tool & Instrument, Inc. | Georgetown, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| medi-plus Instrumente GmbH | TUTTLINGEN-NENDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 7, 2022. 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.