Cleared Traditional

K071612 - MODUS TRILOCK 2.0/2.3/2.5

K071612 is an FDA 510(k) clearance for MODUS TRILOCK 2.0/2.3/2.5, manufactured by Medartis AG. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K071612

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.

JEY Device Classification - Class 2, Special Controls

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 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K071612.
OSTEOMED MODULAR LOCKING FIXATION SYSTEM
K080694 · Osteomed LP · May 2008
SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
K080331 · Synthes (Usa) · Apr 2008
ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
K072528 · Prosurg, Inc. · Dec 2007
XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES
K070737 · Prosurg, Inc. · Jul 2007
THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
K063790 · Synthes (Usa) · Apr 2007
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
K062789 · Synthes (Usa) · Feb 2007