Cleared Traditional

K180249 - OmniPore DUROMAX Surgical Implants

K180249 is the FDA 510(k) clearance for OmniPore DUROMAX Surgical Implants by Matrix Surgical Holdings, LLC/Matrix Surgical USA. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K180249 · Matrix Surgical Holdings, LLC/Matrix Surgical USA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
255d
Days
Class 2
Risk

K180249 is an FDA 510(k) clearance for the OmniPore DUROMAX Surgical Implants. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Matrix Surgical Holdings, LLC/Matrix Surgical USA (Atlanta, US). The FDA issued a Cleared decision on October 11, 2018 after a review of 255 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 Matrix Surgical Holdings, LLC/Matrix Surgical USA devices

Submission Details

510(k) Number K180249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2018
Decision Date October 11, 2018
Days to Decision 255 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
128d slower than avg
Panel avg: 127d · This submission: 255d
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 Consultant

Regulatory Resources Group, Inc.
Julie Stephens

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JEY Plate, Bone

All 156
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