Product Code: JDC FDA class 2 21 CFR 888.3150

Prosthesis, Elbow, Constrained, Cemented

Orthopedic

A constrained cemented elbow prosthesis is a fully linked implantable joint replacement device fixed with bone cement that provides a rigid or semi-rigid hinge connection between the humeral and ulnar components, used for patients with severe elbow instability or bone loss where an unconstrained design would be inadequate. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JDC, regulated under 21 CFR 888.3150, within the Orthopedic medical specialty. This device is an implant.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code JDC in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: JDC
Device Class: FDA class 2
Regulation Number: 888.3150
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K181362	TEMA Elbow System	Feb 16, 2019	Substantially Equivalent	Lima Corporate S.P.A.
K181307	Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow	Jan 28, 2019	Substantially Equivalent	Zimmer, Inc.
K153398	Comprehensive SRS/Nexel Elbow	Feb 03, 2016	Substantially Equivalent	Biomet Manufacturing Corp
K150501	Zimmer Nexel Total Elbow Ulnar Cement Diverter	Apr 23, 2015	Substantially Equivalent	Zimmer, Inc.
K123862	ZIMMER NEXEL TOTAL ELBOW	Mar 12, 2013	Substantially Equivalent	Zimmer, Inc.
K090473	DISCOVERY ELBOW - X-SMALL	Mar 25, 2009	Substantially Equivalent	Biomet Manufacturing Corp
K060696	ACCLAIM TOTAL ELBOW SYSTEM	Apr 14, 2006	Substantially Equivalent	DePuy Orthopaedics, Inc.
K053189	COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES	Dec 09, 2005	Substantially Equivalent	Zimmer, Inc.
K051975	POROUS COATED DISCOVERY ELBOW	Sep 06, 2005	Substantially Equivalent	Biomet, Inc.
K042664	LPS UPPER EXTREMITY	Dec 08, 2004	Substantially Equivalent	Depuy, Inc.
K040389	COONRAD/MORREY ELBOW CEMENT RESTRICTOR	May 17, 2004	Substantially Equivalent	Zimmer, Inc.
K033280	DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM	Dec 19, 2003	Substantially Equivalent	Biomet, Inc.
K013042	DISCOVERY ELBOW	Oct 10, 2001	Substantially Equivalent	Biomet Orthopedics, Inc.
K003253	BIOMET'S MINIMALLY CONSTRAINED ELBOW	Jan 12, 2001	Substantially Equivalent	Biomet, Inc.
K000003	TORNIER TOTAL ELBOW PROSTHESIS	Oct 02, 2000	Substantially Equivalent	Tornier
K001989	COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES	Jul 25, 2000	Substantially Equivalent	Zimmer, Inc.
K000683	MODIFIED SINGLE AXLE TOTAL ELBOW	Jun 27, 2000	Substantially Equivalent	Biomet, Inc.
K992656	DEPUY TOTAL ELBOW SYSTEM	Nov 05, 1999	Substantially Equivalent	DePuy Orthopaedics, Inc.
K983036	SINGLE AXLE TOTAL ELBOW	Apr 30, 1999	Substantially Equivalent	Biomet, Inc.
K982398	BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW	Aug 11, 1998	Substantially Equivalent	Biomet, Inc.
K980502	OSTEONICS TOTAL ELBOW SYSTEM	May 05, 1998	Substantially Equivalent	Osteonics Corp.
K980428	BIOMET BIAXIAL TOTAL ELBOW	May 05, 1998	Substantially Equivalent	Biomet, Inc.
K973357	COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN	Mar 02, 1998	Substantially Equivalent	Zimmer, Inc.
K955916	TOWNLEY TOTAL ELBOW SYSTEM	Aug 08, 1996	Substantially Equivalent	Biologically Oriented Prostheses
K901581	GSB ELBOW	Oct 22, 1990	Substantially Equivalent	Allo Pro Corp.
K904021	PNEUMOTHORAX KIT, MODIFICATION	Oct 09, 1990	Substantially Equivalent	Arrow Intl., Inc.
K883665	COONRAD III TOTAL ELBOW	Feb 03, 1989	Substantially Equivalent for Some Indications	Zimmer, Inc.
K872084	POROCOAT MARK II TOTAL ELBOW	Jun 25, 1987	Substantially Equivalent for Some Indications	Depuy, Inc.
K861680	OSTEONICS ELBOW PROSTHESIS	Jun 27, 1986	Substantially Equivalent	Osteonics Corp.