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JDC — Prosthesis, Elbow, Constrained, Cemented Class II

FDA Device Classification

FDA product code JDC covers "Prosthesis, Elbow, Constrained, Cemented", a Class II medical device regulated under 21 CFR 888.3150. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JDC
Device Class
Class II
Regulation Number
888.3150
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K181362lima corporateTEMA Elbow SystemFebruary 16, 2019
K181307zimmerZimmer Nexel Total Elbow, Connrad/Morrey Total ElbowJanuary 28, 2019
K153398biomet manufacturingComprehensive SRS/Nexel ElbowFebruary 3, 2016
K150501zimmerZimmer Nexel Total Elbow Ulnar Cement DiverterApril 23, 2015
K123862zimmerZIMMER NEXEL TOTAL ELBOWMarch 12, 2013
K090473biomet manufacturingDISCOVERY ELBOW - X-SMALLMarch 25, 2009
K060696depuy orthopaedicsACCLAIM TOTAL ELBOW SYSTEMApril 14, 2006
K053189zimmerCOONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIESDecember 9, 2005
K051975biometPOROUS COATED DISCOVERY ELBOWSeptember 6, 2005
K042664depuyLPS UPPER EXTREMITYDecember 8, 2004
K040389zimmerCOONRAD/MORREY ELBOW CEMENT RESTRICTORMay 17, 2004
K033280biometDISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEMDecember 19, 2003
K013042biomet orthopedicsDISCOVERY ELBOWOctober 10, 2001
K003253biometBIOMET'S MINIMALLY CONSTRAINED ELBOWJanuary 12, 2001
K000003tornierTORNIER TOTAL ELBOW PROSTHESISOctober 2, 2000
K001989zimmerCOONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIESJuly 25, 2000
K000683biometMODIFIED SINGLE AXLE TOTAL ELBOWJune 27, 2000
K992656depuy orthopaedicsDEPUY TOTAL ELBOW SYSTEMNovember 5, 1999
K983036biometSINGLE AXLE TOTAL ELBOWApril 30, 1999
K982398biometBIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOWAugust 11, 1998

FDA data resources