Cleared Traditional

K973357 - COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN

K973357 is an FDA 510(k) clearance for COONRAD/MORREY TOTAL ELBOW, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JDC cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K973357 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
175d
Days
Class 2
Risk

K973357 is an FDA 510(k) clearance for the COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN. Classified as Prosthesis, Elbow, Constrained, Cemented (product code JDC), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 2, 1998 after a review of 175 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3150 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer, Inc. devices

FDA 510(k) Submission Details - K973357

510(k) Number K973357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date March 02, 1998
Days to Decision 175 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 122d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDC Device Classification - Class 2, Special Controls

Product Code JDC Prosthesis, Elbow, Constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDC Prosthesis, Elbow, Constrained, Cemented

All 27
Devices cleared under the same product code (JDC) and FDA review panel - the closest regulatory comparables to K973357.
BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW
K982398 · Biomet, Inc. · Aug 1998
BIOMET BIAXIAL TOTAL ELBOW
K980428 · Biomet, Inc. · May 1998
OSTEONICS TOTAL ELBOW SYSTEM
K980502 · Osteonics Corp. · May 1998
TOWNLEY TOTAL ELBOW SYSTEM
K955916 · Biologically Oriented Prostheses · Aug 1996
PNEUMOTHORAX KIT, MODIFICATION
K904021 · Arrow Intl., Inc. · Oct 1990
COONRAD III TOTAL ELBOW
K883665 · Zimmer, Inc. · Feb 1989