Cleared Traditional

Omnia Medical Trauma Screws (K192096) - FDA 510(k) Clearance

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

K192096 · Omnia Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
206d
Days
Class 2
Risk

K192096 is an FDA 510(k) clearance for the Omnia Medical Trauma Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Omnia Medical, LLC (Morgantown,, US). The FDA issued a Cleared decision on February 27, 2020 after a review of 206 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Omnia Medical, LLC devices

Submission Details

510(k) Number K192096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2019
Decision Date February 27, 2020
Days to Decision 206 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 122d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 Orthopedic devices follow this clearance model.

Regulatory Consultant

Jalex Medical
Daniel Johnson

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 - HWC Screw, Fixation, Bone

All 409
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K192096.
S4 Screw System
K191995 · Subchondral Solutions, Inc. · Apr 2020
T2 ICF
K193366 · Stryker GmbH · Mar 2020
restor3d Metallic Interference Screw
K193491 · Restor3d · Mar 2020
Titanium Interference Screws
K193451 · Biomet, Inc. · Feb 2020
Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
K193156 · Arthrex, Inc. · Feb 2020
Tyber Medical Trauma Screws
K192975 · Tyber Medical, LLC · Jan 2020