Cleared Traditional

K071612 - MODUS TRILOCK 2.0/2.3/2.5

K071612 is the FDA 510(k) clearance for MODUS TRILOCK 2.0/2.3/2.5 by Medartis AG. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K071612 · Medartis AG · Dental device
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Sep 2007
Decision
90d
Days
Class 2
Risk

K071612 is an FDA 510(k) clearance for the MODUS TRILOCK 2.0/2.3/2.5. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Medartis AG (San Diego, US). The FDA issued a Cleared decision on September 11, 2007 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Medartis AG devices

Submission Details

510(k) Number K071612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2007
Decision Date September 11, 2007
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K071612.
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K080331 · Synthes (Usa) · Apr 2008
THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
K063790 · Synthes (Usa) · Apr 2007
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
K062789 · Synthes (Usa) · Feb 2007
LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES
K063052 · Walter Lorenz Surgical, Inc. · Jan 2007