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)
Top companies in JDC
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. AXLE PIN ASSY LARGE ELBOW COBALT CHROME
Catalog No. C-M112-2-500
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
JDC | K980502 |
| Mar 16, 2023 | Limacorporate S.p.A TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling) Open, Classified |
JDC | K181362 |
| Dec 12, 2019 | Zimmer 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 |
JDC | K001989 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Coorad Morrey Total Elbow, Item Nos. 32810502501
32810502701
32810502900
32810503000
32810600012
32810600013
32855510796
32855510797
32855510799
32855510800
32855510801
32855510805
32855510822
3285551 Terminated |
JDC | K001989 |
| Mar 14, 2018 | Zimmer 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 |
JDC | K001989 |
| Sep 8, 2016 | Zimmer 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 |
JDC | K001989 |
| Jun 26, 2014 | Biomet, 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 |
JDC | K013042 |
| Dec 18, 2012 | Zimmer, 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 |
JDC | K001989 |
| Dec 18, 2012 | Zimmer, 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 |
JDC | K973357 |
| Feb 21, 2012 | Biomet, 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 |
JDC | K051975 |
| Jun 24, 2011 | Biomet, 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 |
JDC | K051975 |
| Apr 2, 2009 | Zimmer 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 |
JDC | K001989 |
| Apr 2, 2009 | Zimmer 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 |
JDC | K001989 |
| Apr 2, 2009 | Zimmer 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 |
JDC | K053189 |
| Apr 2, 2009 | Zimmer 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 |
JDC | K053189 |
| Apr 2, 2009 | Zimmer 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 |
JDC | K001989 |
| Apr 2, 2009 | Zimmer 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 |
JDC | K001989 |
| Oct 3, 2008 | Biomet, 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 |
JDC | K013042 |
| Oct 3, 2008 | Biomet, 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 |
JDC | K013042 |
| Jul 20, 2004 | Zimmer 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 |
JDC | None listed |
| Jul 20, 2004 | Zimmer 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 |
JDC | K001989 |
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