Product code JDC— Orthopedic
ACCLAIM TOTAL ELBOW SYSTEM
- Classification name
- Prosthesis, Elbow, Constrained, Cemented
- Device class
- Class 2
- Regulation
- 21 CFR 888.3150
- Advisory panel
- Orthopedic
- Total cleared
- 29
- First cleared
- Most recent
Market context for product code JDC
FDA has cleared devices under product code JDC between 1986 and 2019, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2019
- 2016
- 2015
- 2013
- 2009
- 2006
- 2005
- 2004
- 2003
- 2001
- 2000
- 1999
- 1998
- 1996
- 1990
Top applicants under product code JDC
Adverse events under product code JDC
product code JDC- Injury
- 1,050
- Total
- 1,050
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code JDC
- K181362 — TEMA Elbow System
- K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
- K153398 — Comprehensive SRS/Nexel Elbow
- K150501 — Zimmer Nexel Total Elbow Ulnar Cement Diverter
- K123862 — ZIMMER NEXEL TOTAL ELBOW
- K090473 — DISCOVERY ELBOW - X-SMALL
- K060696 — ACCLAIM TOTAL ELBOW SYSTEM
- K053189 — COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES
- K051975 — POROUS COATED DISCOVERY ELBOW
- K042664 — LPS UPPER EXTREMITY
- K040389 — COONRAD/MORREY ELBOW CEMENT RESTRICTOR
- K033280 — DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
- K013042 — DISCOVERY ELBOW
- K003253 — BIOMET'S MINIMALLY CONSTRAINED ELBOW
- K000003 — TORNIER TOTAL ELBOW PROSTHESIS
- K001989 — COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
- K000683 — MODIFIED SINGLE AXLE TOTAL ELBOW
- K992656 — DEPUY TOTAL ELBOW SYSTEM
- K983036 — SINGLE AXLE TOTAL ELBOW
- K982398 — BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW
- K980428 — BIOMET BIAXIAL TOTAL ELBOW
- K980502 — OSTEONICS TOTAL ELBOW SYSTEM
- K973357 — COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN
- K955916 — TOWNLEY TOTAL ELBOW SYSTEM
- K901581 — GSB ELBOW
- K904021 — PNEUMOTHORAX KIT, MODIFICATION
- K883665 — COONRAD III TOTAL ELBOW
- K872084 — POROCOAT MARK II TOTAL ELBOW
- K861680 — OSTEONICS ELBOW PROSTHESIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.