Data / Medical devices / Prosthesis, Elbow, Hemi-, Radial, Polymer

Prosthesis, Elbow, Hemi-, Radial, Polymer (KWI): 77 FDA-registered makers in 8 countries

77 establishments in 8 countries are registered with the FDA to make Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI, Class 2, 21 CFR 888.3170). 19 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on July 30, 2026, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

KWI

Device class

2

Regulation

888.3170

Medical specialty

Orthopedic

Implant

Yes

Makers by country

Makers of Prosthesis, Elbow, Hemi-, Radial, Polymer

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.

Updated July 30, 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.