ClearanceBrief
Panels › Orthopedic › Product code JDC · Class 2

Prosthesis, Elbow, Constrained, Cemented

Regulation 888.3150

0510(k)s in 12 months (29 all time)
1recalls in 12 months (21 all time)
20recalls that name a 510(k)
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Top companies in JDC

DateFirm and productCodeLinked 510(k)
Sep 16, 2026Howmedica Osteonics Corp.
AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Open, Classified
JDCK980502
Mar 16, 2023Limacorporate S.p.A
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Open, Classified
JDCK181362
Dec 12, 2019Zimmer Biomet, Inc.
Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/p
Terminated
JDCK001989
Oct 10, 2019Zimmer Biomet, Inc.
Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510822 3285551
Terminated
JDCK001989
Mar 14, 2018Zimmer Biomet, Inc.
Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
Terminated
JDCK001989
Sep 8, 2016Zimmer Biomet, Inc.
Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity i
Terminated
JDCK001989
Jun 26, 2014Biomet, Inc.
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthropla
Terminated
JDCK013042
Dec 18, 2012Zimmer, Inc.
Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the h
Terminated
JDCK001989
Dec 18, 2012Zimmer, Inc.
COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage
Terminated
JDCK973357
Feb 21, 2012Biomet, Inc.
Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet Orthopedics Warsaw IN 46581. Intended for primary and revision joint arthroplasty for use in cem
Terminated
JDCK051975
Jun 24, 2011Biomet, Inc.
Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V ALLOY, IF USED FOR REVISION SURGERY, INSTRUMENTS 414926 & 414923 MAY BE REQUIR
Terminated
JDCK051975
Apr 2, 2009Zimmer Inc.
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, long, sterile, Zimmer, Warsaw, IN; REF 32-8105-093-02. The device is utilized for a total elbow
Terminated
JDCK001989
Apr 2, 2009Zimmer Inc.
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, long, sterile, Zimmer, Warsaw, IN; REF 32-8105-093-01. The device is utilized for a total elbow a
Terminated
JDCK001989
Apr 2, 2009Zimmer Inc.
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, 3 inch length, sterile, Zimmer, Warsaw, IN; REF 32-8105-043-02. The device is utilized for a tot
Terminated
JDCK053189
Apr 2, 2009Zimmer Inc.
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, 3 inch length, sterile, Zimmer, Warsaw, IN; REF 32-8105-043-01. The device is utilized for a tota
Terminated
JDCK053189
Apr 2, 2009Zimmer Inc.
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 6 inch length, sterile, Zimmer Inc, Warsaw, IN; REF 32-8105-027-06. The device is utilized for a total elbow arthropl
Terminated
JDCK001989
Apr 2, 2009Zimmer Inc.
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile, Zimmer Inc., Warsaw, IN; REF 32-8105-027-04. The device is utilized for a total elbow arthrop
Terminated
JDCK001989
Oct 3, 2008Biomet, Inc.
Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The prod
Terminated
JDCK013042
Oct 3, 2008Biomet, Inc.
Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The produ
Terminated
JDCK013042
Jul 20, 2004Zimmer Inc.
Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, right, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-02.
Terminated
JDCNone listed
Jul 20, 2004Zimmer Inc.
Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-01.
Terminated
JDCK001989

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