Cleared Traditional

K000003 - TORNIER TOTAL ELBOW PROSTHESIS

K000003 is an FDA 510(k) clearance for TORNIER TOTAL ELBOW PROSTHESIS, manufactured by Tornier. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K000003

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.

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 K000003.
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
K033280 · Biomet, Inc. · Dec 2003
DISCOVERY ELBOW
K013042 · Biomet Orthopedics, Inc. · Oct 2001
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