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Data / Medical devices / Prosthesis, Finger, Constrained, Polymer

Prosthesis, Finger, Constrained, Polymer (KYJ): 16 FDA-registered makers in 5 countries

16 establishments in 5 countries are registered with the FDA to make Prosthesis, Finger, Constrained, Polymer (product code KYJ, Class 2, 21 CFR 888.3230). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on December 14, 2023, and lists 3 recall events (0 Class I). FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
KYJ
Device class
2
Regulation
888.3230
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States11
United Kingdom2
Italy1
Switzerland1
France1

Makers of Prosthesis, Finger, Constrained, 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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer3February 9, 2009000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer3February 9, 2009000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer2January 12, 2009000api.fda.gov
BRM Extremities SRLCivate (LC) Lombardy, ItalyManufacturer1April 4, 2023000api.fda.gov
Keri MedicalPlan-les-Ouates Geneve, SwitzerlandComplaint file establishment, Specification developer1July 27, 2022000api.fda.gov
Osteotec LimitedNewbury West Berkshire, United KingdomExporter to the US, Specification developer1April 17, 2015010api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1December 14, 2023000api.fda.gov
Banister Tool, Inc.Pflugerville, TX, United StatesContract manufacturer0000api.fda.gov
Clinical Polymer Technologies LtdCoalville Leicestershire, United KingdomContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
MRPCButler, WI, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCShakopee, MN, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Statice SABESANCON Doubs, FranceContract manufacturer0000api.fda.gov

Updated December 14, 2023. 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.