Cleared Traditional

K000003 - TORNIER TOTAL ELBOW PROSTHESIS (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000003 · Tornier · Orthopedic device
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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
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.