Cleared Special

K031218 - MODIFICATION TO TORNIER TOTAL ELBOW PRO...

K031218 is the FDA 510(k) clearance for MODIFICATION TO TORNIER TOTAL ELBOW PRO... by Tornier. It is a Class 2 Orthopedic device (product code JDB) cleared through the Special 510(k) pathway after a 29-day FDA review.

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
Combination Product No
PCCP Authorized No
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 22
Devices cleared under the same product code (JDB) and FDA review panel - the closest regulatory comparables to K031218.
LATITUDE ELBOW PROTHESIS
K070787 · Tornier · Aug 2007
RHS
K060438 · Tornier · Apr 2006
TORNIER ELBOW PROSTHESIS
K050848 · Tornier · Jul 2005
TORNIER TOTAL ELBOW PROSTHESIS
K011567 · Tornier · Jun 2001
CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
K983141 · Johnson & Johnson Professionals, Inc. · Nov 1998
ABC TOTAL ELBOW PROTHESIS
K972691 · Biomet, Inc. · Oct 1997