Cleared Special

MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS (K031218) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031218 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
29d
Days
Class 2
Risk

K031218 is an FDA 510(k) clearance for the MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Tornier (Montbonnot, FR). The FDA issued a Cleared decision on May 16, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3160 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tornier devices

Submission Details

510(k) Number K031218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2003
Decision Date May 16, 2003
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDB Prosthesis, Elbow, Semi-constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3160
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 - JDB Prosthesis, Elbow, Semi-constrained, Cemented

All 26
Devices cleared under the same product code (JDB) and FDA review panel - the closest regulatory comparables to K031218.
TEMA Elbow system - Line extension
K222807 · Lima Corporate S.P.A. · Oct 2022
LATITUDE EV™ Total Elbow Arthroplasty
K193247 · Tornier, Inc. · Aug 2020
LATITUDE EV Total Elbow Arthroplasty
K182461 · Tornier, Inc. · Dec 2018
ABC TOTAL ELBOW PROTHESIS
K972691 · Biomet, Inc. · Oct 1997
SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
K960087 · Wrightmedicaltechnologyinc · Sep 1996
SORBIE TOTAL ELBOW SYSTEM
K955099 · Wrightmedicaltechnologyinc · Feb 1996