Data / Medical devices / Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis (QKW): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis (product code QKW, Class 2, 21 CFR 888.3695). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on December 16, 2022, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QKW
- Device class
- 2
- Regulation
- 888.3695
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| France | 3 |
Makers of Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
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 |
|---|---|---|---|---|---|---|---|---|
| Tornier S.A.S | Montbonnot Saint-Martin Isere, France | Manufacturer | 1 | December 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Tornier, SAS | GRENOBLE CEDEX 1 Isere, France | Manufacturer | 1 | December 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Tornier S.A.S. | Montbonnot Saint-Martin Isere, France | Complaint file establishment, Manufacturer | 1 | December 16, 2022 | 0 | 0 | 0 | api.fda.gov |
Updated December 16, 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.