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Data / Medical devices / Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained (JWJ): 23 FDA-registered makers in 5 countries

23 establishments in 5 countries are registered with the FDA to make Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained (product code JWJ, Class 2, 21 CFR 888.3800). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on November 1, 2024, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.

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Product code
JWJ
Device class
2
Regulation
888.3800
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States18
Switzerland2
United Kingdom1
Ireland1
Germany1

Makers of Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

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 StatesManufacturer3May 30, 2024000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer2July 29, 2008000api.fda.gov
Arthrosurface, Inc.W Bridgewater, MA, United StatesManufacturer1October 15, 2020000api.fda.gov
Extremity Medical, LLCParsippany, NJ, United StatesSpecification developer1March 4, 2020000api.fda.gov
Janco, Inc.Rollinsford, NH, United StatesContract manufacturer, Repackager or relabeler1March 4, 2020000api.fda.gov
Skeletal Dynamics, IncMiami, FL, United StatesComplaint file establishment, Specification developer1July 3, 2024000api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandManufacturer, Specification developer1December 2, 2002000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Depuy Intl., Ltd.Leeds, United KingdomSpecification developer0000api.fda.gov
Depuy Ireland UCCo. Cork Munster, IrelandSpecification developer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedics Switzerland GMBHBaden-Daettwil Aargau, SwitzerlandContract manufacturer0000api.fda.gov
Orchid Orthopedics-ChelseaChelsea, MI, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
SMT Schilling Metalltechnik GMBHMUHLHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov

Updated November 1, 2024. 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.