Cleared Traditional

K992682 - MODUS 2.5 MANDIBULAR RECONSTRUCTION SET

K992682 is an FDA 510(k) clearance for MODUS 2.5 MANDIBULAR RECONSTRUCTION SET, 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 106-day FDA review.

K992682 · Medartis AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
106d
Days
Class 2
Risk

K992682 is an FDA 510(k) clearance for the MODUS 2.5 MANDIBULAR RECONSTRUCTION SET. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Medartis AG (Waltham, US). The FDA issued a Cleared decision on November 24, 1999 after a review of 106 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 - K992682

510(k) Number K992682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1999
Decision Date November 24, 1999
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
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 K992682.
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
K001238 · Walter Lorenz Surgical, Inc. · May 2000
MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES
K994154 · KLS-Martin L.P. · Feb 2000
MODUS SAGITTAL SPLIT PLATE
K993862 · The Straumann Co. · Dec 1999
MODUS 2.5 MANDIBULAR TRAUMA SET
K992683 · Medartis AG · Nov 1999
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K992330 · Biomedics · Nov 1999
LACTOSORB SHEETS
K992158 · Biomet, Inc. · Aug 1999