Cleared Traditional

K000003 - TORNIER TOTAL ELBOW PROSTHESIS

K000003 is the FDA 510(k) clearance for TORNIER TOTAL ELBOW PROSTHESIS by Tornier. It is a Class 2 Orthopedic device (product code JDC) cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K000003 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
273d
Days
Class 2
Risk

K000003 is an FDA 510(k) clearance for the TORNIER TOTAL ELBOW PROSTHESIS. Classified as Prosthesis, Elbow, Constrained, Cemented (product code JDC), Class II - Special Controls.

Submitted by Tornier (Pleasant Hill, US). The FDA issued a Cleared decision on October 2, 2000 after a review of 273 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 Tornier devices

Submission Details

510(k) Number K000003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2000
Decision Date October 02, 2000
Days to Decision 273 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
151d slower than avg
Panel avg: 122d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 25
Devices cleared under the same product code (JDC) and FDA review panel - the closest regulatory comparables to K000003.
COONRAD/MORREY ELBOW CEMENT RESTRICTOR
K040389 · Zimmer, Inc. · May 2004
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
K033280 · Biomet, Inc. · Dec 2003
BIOMET'S MINIMALLY CONSTRAINED ELBOW
K003253 · Biomet, Inc. · Jan 2001
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
K001989 · Zimmer, Inc. · Jul 2000
MODIFIED SINGLE AXLE TOTAL ELBOW
K000683 · Biomet, Inc. · Jun 2000
DEPUY TOTAL ELBOW SYSTEM
K992656 · DePuy Orthopaedics, Inc. · Nov 1999