Atlas FDA

JDC

29 FDA 510(k) clearances · Product code

85 daysmedian time to decision
256 days90th percentile
29clearances measured

FDA profile

Official device name
Prosthesis, Elbow, Constrained, Cemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3150
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 157 · 2022: 129 · 2023: 187 · 2024: 175 · 2025: 216 · 2026: 103
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TEMA Elbow System (K181362)Lima Corporate S.P.A.2019-02-16
Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow (K181307)Zimmer, Inc.2019-01-28
Comprehensive SRS/Nexel Elbow (K153398)Biomet Manufacturing Corp2016-02-03
Zimmer Nexel Total Elbow Ulnar Cement Diverter (K150501)Zimmer, Inc.2015-04-23
ZIMMER NEXEL TOTAL ELBOW (K123862)Zimmer, Inc.2013-03-12
DISCOVERY ELBOW - X-SMALL (K090473)Biomet Manufacturing Corp2009-03-25
ACCLAIM TOTAL ELBOW SYSTEM (K060696)DePuy Orthopaedics, Inc.2006-04-14
COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES (K053189)Zimmer, Inc.2005-12-09
POROUS COATED DISCOVERY ELBOW (K051975)Biomet, Inc.2005-09-06
LPS UPPER EXTREMITY (K042664)Depuy, Inc.2004-12-08
COONRAD/MORREY ELBOW CEMENT RESTRICTOR (K040389)Zimmer, Inc.2004-05-17
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM (K033280)Biomet, Inc.2003-12-19
DISCOVERY ELBOW (K013042)Biomet Orthopedics, Inc.2001-10-10
BIOMET'S MINIMALLY CONSTRAINED ELBOW (K003253)Biomet, Inc.2001-01-12
TORNIER TOTAL ELBOW PROSTHESIS (K000003)Tornier2000-10-02
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES (K001989)Zimmer, Inc.2000-07-25
MODIFIED SINGLE AXLE TOTAL ELBOW (K000683)Biomet, Inc.2000-06-27
DEPUY TOTAL ELBOW SYSTEM (K992656)DePuy Orthopaedics, Inc.1999-11-05
SINGLE AXLE TOTAL ELBOW (K983036)Biomet, Inc.1999-04-30
BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW (K982398)Biomet, Inc.1998-08-11
OSTEONICS TOTAL ELBOW SYSTEM (K980502)Osteonics Corp.1998-05-05
BIOMET BIAXIAL TOTAL ELBOW (K980428)Biomet, Inc.1998-05-05
COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN (K973357)Zimmer, Inc.1998-03-02
TOWNLEY TOTAL ELBOW SYSTEM (K955916)Biologically Oriented Prostheses1996-08-08
GSB ELBOW (K901581)Allo Pro Corp.1990-10-22
PNEUMOTHORAX KIT, MODIFICATION (K904021)Arrow Intl., Inc.1990-10-09
COONRAD III TOTAL ELBOW (K883665)Zimmer, Inc.1989-02-03
POROCOAT MARK II TOTAL ELBOW (K872084)Depuy, Inc.1987-06-25
OSTEONICS ELBOW PROSTHESIS (K861680)Osteonics Corp.1986-06-27

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Every clearance here is in the API, with alerts when new ones post.