Cleared Traditional

ORTRAUTEK TRAUMA SYSTEM (K032520) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032520 · Tekka · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
89d
Days
Class 2
Risk

K032520 is an FDA 510(k) clearance for the ORTRAUTEK TRAUMA SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Tekka (Bethesda, US). The FDA issued a Cleared decision on November 12, 2003 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tekka devices

Submission Details

510(k) Number K032520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2003
Decision Date November 12, 2003
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
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 90
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K032520.
MODIFICATION TO SYNTHES CRANIAL PLATES
K042987 · Synthes (Usa) · Nov 2004
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K042365 · Synthes (Usa) · Nov 2004
SYNTHES (USA) CRANIOFACIAL PLATES
K040272 · Synthes (Usa) · Feb 2004
1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES
K033121 · Synthes (Usa) · Oct 2003
SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES
K033160 · Synthes (Usa) · Oct 2003
SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
K031761 · Synthes (Usa) · Sep 2003