Cleared Special

MODUS TITANIUM OSTEOSYNTHESIS SYSTEM (K050934) - FDA 510(k) Clearance

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

K050934 · Medartis, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
21d
Days
Class 2
Risk

K050934 is an FDA 510(k) clearance for the MODUS TITANIUM OSTEOSYNTHESIS SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Medartis, Inc. (San Diego, US). The FDA issued a Cleared decision on May 5, 2005 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental 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 Medartis, Inc. devices

Submission Details

510(k) Number K050934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2005
Decision Date May 05, 2005
Days to Decision 21 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 127d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 97
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K050934.
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
K062789 · Synthes (Usa) · Feb 2007
AESCULAP CRANIOFACIAL PLATE AND SCREW
K060492 · Aesculap, Inc. · Apr 2006
SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM
K050608 · Synthes (Usa) · May 2005
SYNTHES RAPID RESORBABLE TACK SYSTEM
K050204 · Synthes (Usa) · Mar 2005
MODIFICATION TO SYNTHES CRANIAL PLATES
K042987 · Synthes (Usa) · Nov 2004
SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM
K042365 · Synthes (Usa) · Nov 2004