Cleared Traditional

K010118 - NORMED MANDIBULAR FIXATION SYSTEM

K010118 is an FDA 510(k) clearance for NORMED MANDIBULAR FIXATION SYSTEM, manufactured by Osteomedics, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K010118 · Osteomedics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
210d
Days
Class 2
Risk

K010118 is an FDA 510(k) clearance for the NORMED MANDIBULAR FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Osteomedics, Inc. (Paramus, US). The FDA issued a Cleared decision on August 14, 2001 after a review of 210 days - an extended review cycle.

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 Osteomedics, Inc. devices

FDA 510(k) Submission Details - K010118

510(k) Number K010118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2001
Decision Date August 14, 2001
Days to Decision 210 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 127d · This submission: 210d
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 248
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K010118.
INION CPS 2.0 ORTHOGNATHIC PLATE
K013039 · Inion , Ltd. · Oct 2001
MACROPORE FX, PS, NS, LP
K012413 · Macropore Biosurgery, Inc. · Sep 2001
STRAUMANN GBR SYSTEM
K011698 · Institut Straumann AG · Aug 2001
LACTOSORB RAPIDFLAP
K003281 · Biomet, Inc. · Aug 2001
MACROPOREPX PEDIATRIC SYSTEM
K002207 · Macropore Biosurgery, Inc. · Jul 2001
MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K011380 · Bioplate, Inc. · May 2001