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

Prosthesis, Toe, Constrained, Polymer (KWH): 19 FDA-registered makers in 5 countries

19 establishments in 5 countries are registered with the FDA to make Prosthesis, Toe, Constrained, Polymer (product code KWH, Class 2, 21 CFR 888.3720). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on February 13, 2020, and lists 2 recall events (0 Class I). FDA data exported November 2, 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
KWH
Device class
2
Regulation
888.3720
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States13
China3
Italy1
Switzerland1
Malaysia1

Makers of Prosthesis, Toe, 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
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer4January 17, 2003000api.fda.gov
Fusion Orthopedics Usa, LLCMesa, AZ, United StatesComplaint file establishment, Specification developer3October 21, 2019000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer3January 14, 2011000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer3January 14, 2011000api.fda.gov
In2bones Usa, LLCCordova, TN, United StatesManufacturer2February 23, 2018000api.fda.gov
OsteomedAddison, TX, United StatesManufacturer2November 26, 2002000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer1January 7, 2000000api.fda.gov
BRM Extremities SRLCivate (LC) Lombardy, ItalyManufacturer1February 13, 2020000api.fda.gov
Smith & Nephew Orthopaedics AGAARAU Aargau, SwitzerlandManufacturer1July 6, 1995000api.fda.gov
Hangzhou Sino-Mim Technology Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Kingj Medical Co., LtdZhangjiagang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Medical Device And Implants LLCLancaster, PA, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Suzhou Kangli Orthopaedics Instrument Co., Ltd.Zhangjiagang City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith and Nephew Operations Sdn. BhdPenang Pulau Pinang, MalaysiaManufacturer0000api.fda.gov

Updated February 13, 2020. 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.