Atlas FDA

COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES

FDA 510(k) clearance K001989 · decided 2000-07-25

Clearance details

K-number
K001989
Device name
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2000-06-29
Decision date
2000-07-25
Days to decision
26 days
Clearance type
Special
Product code
JDC
Device class
2
Regulation number
888.3150
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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

Recalls involving this device

RecordFirmDate
Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 recall (Z-1239-2018)Zimmer Biomet, Inc.2018-03-14
Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold recall (Z-2752-2016)Zimmer Biomet, Inc.2016-09-08
Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals ST recall (Z-0538-2013)Zimmer, Inc.2012-12-18
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch l recall (Z-1053-2009)Zimmer Inc.2009-04-02
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 6 inch l recall (Z-1054-2009)Zimmer Inc.2009-04-02
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra s recall (Z-1057-2009)Zimmer Inc.2009-04-02
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra s recall (Z-1058-2009)Zimmer Inc.2009-04-02
Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. recall (Z-0767-04)Zimmer Inc.2004-07-20

PMA approvals by this applicant

RecordFirmDate
NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095)Zimmer, Inc.2025-08-18
NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093)Zimmer, Inc.2025-04-09
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094)Zimmer, Inc.2025-04-01
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092)Zimmer, Inc.2024-12-12
NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091)Zimmer, Inc.2024-07-05
NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090)Zimmer, Inc.2024-05-17
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089)Zimmer, Inc.2024-04-04
NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088)Zimmer, Inc.2024-02-13