Cleared Traditional

K180204 - CranioMaxillofacial Fixation (CMF) System - CMF Visionare (FDA 510(k) Clearance)

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

K180204 · Visionare, LLC · Dental device
Dec 2018
Decision
338d
Days
Class 2
Risk

K180204 is an FDA 510(k) clearance for the CranioMaxillofacial Fixation (CMF) System - CMF Visionare. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Visionare, LLC (Fort Myers, US). The FDA issued a Cleared decision on December 28, 2018 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K180204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2018
Decision Date December 28, 2018
Days to Decision 338 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 158d · This submission: 338d
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 8
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K180204.
Southern Craniomaxillofacial (CMF) System
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KLS Martin Oral-Max Implants MR Conditional (bundled)
K241314 · KLS-Martin L.P. · Aug 2024
MRI Universal
K240651 · Stryker Leibinger GmbH & Co KG · Jul 2024
Stryker Resorbable Fixation System
K230733 · Stryker Leibinger GmbH & Co KG · Aug 2023
Universal CMF System
K221855 · Stryker Leibinger GmbH & Co KG · Nov 2022