Prosthesis, Elbow, Constrained, Cemented
FDA product code JDC · Class II (moderate risk) · 21 CFR 888.3150 · Orthopedic
29510(k) clearances
0PMA approvals
19recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181362 | TEMA Elbow SystemJDC · Traditional | Lima Corporate S.P.A. | 02/16/2019SE |
| K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowJDC · Traditional | Zimmer, Inc. | 01/28/2019SE |
| K153398 | Comprehensive SRS/Nexel ElbowJDC · Traditional | Biomet Manufacturing Corp | 02/03/2016SE |
| K150501 | Zimmer Nexel Total Elbow Ulnar Cement DiverterJDC · Traditional | Zimmer, Inc. | 04/23/2015SE |
| K123862 | Zimmer Nexel Total ElbowJDC · Traditional | Zimmer, Inc. | 03/12/2013SE |
| K090473 | Discovery Elbow - X-SmallJDC · Special | Biomet Manufacturing Corp | 03/25/2009SE |
| K060696 | Acclaim Total Elbow SystemJDC · Special | DePuy Orthopaedics, Inc. | 04/14/2006SE |
| K053189 | Coonrad/Morrey Total Elbow, Model 8105 SeriesJDC · Special | Zimmer, Inc. | 12/09/2005SE |
| K051975 | Porous Coated Discovery ElbowJDC · Special | Biomet, Inc. | 09/06/2005SE |
| K042664 | LPS Upper ExtremityJDC · Traditional | Depuy, Inc. | 12/08/2004SE |
| K040389 | Coonrad/Morrey Elbow Cement RestrictorJDC · Traditional | Zimmer, Inc. | 05/17/2004SE |
| K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement SystemJDC · Traditional | Biomet, Inc. | 12/19/2003SE |
| K013042 | Discovery ElbowJDC · Special | Biomet Orthopedics, Inc. | 10/10/2001SE |
| K003253 | Biomet's Minimally Constrained ElbowJDC · Traditional | Biomet, Inc. | 01/12/2001SE |
| K000003 | Tornier Total Elbow ProsthesisJDC · Traditional | Tornier | 10/02/2000SE |
| K001989 | Coonrad/Morrey Total Elbow. Model 32-8105 SeriesJDC · Special | Zimmer, Inc. | 07/25/2000SE |
| K000683 | Modified Single Axle Total ElbowJDC · Special | Biomet, Inc. | 06/27/2000SE |
| K992656 | Depuy Total Elbow SystemJDC · Traditional | DePuy Orthopaedics, Inc. | 11/05/1999SE |
| K983036 | Single Axle Total ElbowJDC · Traditional | Biomet, Inc. | 04/30/1999SE |
| K982398 | Biomet 100% Porous Coated Biaxial Total ElbowJDC · Traditional | Biomet, Inc. | 08/11/1998SE |
| K980502 | Osteonics Total Elbow SystemJDC · Traditional | Osteonics Corp. | 05/05/1998SE |
| K980428 | Biomet Biaxial Total ElbowJDC · Traditional | Biomet, Inc. | 05/05/1998SE |
| K973357 | Coonrad/Morrey Total Elbow, New Hinge PinJDC · Traditional | Zimmer, Inc. | 03/02/1998SE |
| K955916 | Townley Total Elbow SystemJDC · Traditional | Biologically Oriented Prostheses | 08/08/1996SE |
| K901581 | GSB ElbowJDC · Traditional | Allo Pro Corp. | 10/22/1990SE |
| K904021 | Pneumothorax Kit, ModificationJDC · Traditional | Arrow Intl., Inc. | 10/09/1990SE |
| K883665 | Coonrad III Total ElbowJDC · Traditional | Zimmer, Inc. | 02/03/1989SN |
| K872084 | Porocoat Mark II Total ElbowJDC · Traditional | Depuy, Inc. | 06/25/1987SN |
| K861680 | Osteonics Elbow ProsthesisJDC · Traditional | Osteonics Corp. | 06/27/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3195-2026 | AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-1261-2023 Class II | TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the…Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow… | Limacorporate S.p.A | 01/25/2023Open, Classified |
| Z-1000-2020 Class II | Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No.…The lot contained two outer pins instead of one outer and one inner pin. | Zimmer Biomet, Inc. | 12/12/2019Terminated |
| Z-0301-2020 Class II | Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Zimmer Biomet, Inc. | 10/10/2019Terminated |
| Z-1239-2018 Class II | Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number:…One lot of humeral stem implants do not include the humeral bushing components. | Zimmer Biomet, Inc. | 01/24/2018Terminated |
| Z-2752-2016 Class II | Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is…Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow… | Zimmer Biomet, Inc. | 08/16/2016Terminated |
| Z-1925-2014 Class II | DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V…Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when… | Biomet, Inc. | 05/15/2014Terminated |
| Z-0538-2013 Class II | Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals…Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin… | Zimmer, Inc. | 11/19/2012Terminated |
| Z-0537-2013 Class II | COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE…Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin… | Zimmer, Inc. | 11/19/2012Terminated |
| Z-1071-2012 | Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy…A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to… | Biomet, Inc. | 12/14/2011Terminated |
| Z-2660-2011 | Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET -…The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained… | Biomet, Inc. | 04/29/2011Terminated |
| Z-1058-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra…The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the… | Zimmer Inc. | 01/30/2009Terminated |
| Z-1057-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra…The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the… | Zimmer Inc. | 01/30/2009Terminated |
| Z-1056-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra…The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the… | Zimmer Inc. | 01/30/2009Terminated |
| Z-1055-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra…The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the… | Zimmer Inc. | 01/30/2009Terminated |
| Z-1054-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 6 inch…The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the… | Zimmer Inc. | 01/30/2009Terminated |
| Z-1053-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch…The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the… | Zimmer Inc. | 01/30/2009Terminated |
| Z-0033-2009 | Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V…The component in the package is not the correct size. | Biomet, Inc. | 05/23/2008Terminated |
| Z-0032-2009 | Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V…The component in the package is not the correct size. | Biomet, Inc. | 05/23/2008Terminated |