Data / Medical devices / Prosthesis, Chin, Internal
Prosthesis, Chin, Internal (FWP): 8 FDA-registered makers in 2 countries
8 establishments in 2 countries are registered with the FDA to make Prosthesis, Chin, Internal (product code FWP, Class 2, 21 CFR 878.3550). 6 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 66 510(k) clearances under this code, the latest on March 12, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FWP
- Device class
- 2
- Regulation
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 1 |
Makers of Prosthesis, Chin, Internal
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 |
|---|---|---|---|---|---|---|---|---|
| Implantech Associates, Inc. | Ventura, CA, United States | Manufacturer | 21 | December 23, 2020 | 0 | 1 | 0 | api.fda.gov |
| Stryker Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | Complaint file establishment, Specification developer | 8 | March 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Surgical Technology Laboratories Inc. | Lugoff, SC, United States | Manufacturer | 2 | April 22, 2009 | 0 | 0 | 0 | api.fda.gov |
| Dsaart, LLC | Carson City, NV, United States | Manufacturer | 1 | July 2, 2002 | 0 | 1 | 0 | api.fda.gov |
| Hanson Medical, Inc. | Paso Robles, CA, United States | Manufacturer | 1 | November 7, 1997 | 0 | 0 | 0 | api.fda.gov |
| Poriferous, LLC | Newnan, GA, United States | Manufacturer | 1 | January 20, 2016 | 0 | 0 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Howmedica Osteonics Corp | Mahwah, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 12, 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.