Cleared Traditional

K172323 - Omnia Medical VBR

K172323 is an FDA 510(k) clearance for Omnia Medical VBR, manufactured by Omnia Medical, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K172323 · Omnia Medical, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
86d
Days
Class 2
Risk

K172323 is an FDA 510(k) clearance for the Omnia Medical VBR. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Omnia Medical, LLC (Morgantown, US). The FDA issued a Cleared decision on October 26, 2017 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K172323

510(k) Number K172323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2017
Decision Date October 26, 2017
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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
Kevin Majka

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 - MQP Spinal Vertebral Body Replacement Device

All 278
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K172323.
Blustone Synergy Silica System
K172330 · Blustone Synergy · Dec 2017
T2 STRATOSPHERE™ Expandable Corpectomy System
K173125 · Medtronic Sofamor Danek · Dec 2017
FORTIFY Corpectomy Spacers
K162315 · Globus Medical, Inc. · Nov 2017
Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
K171686 · Choicespine · Sep 2017
CAPRI Corpectomy Cage System
K171704 · K2m · Aug 2017
VerteFIT Corpectomy Cage System
K162133 · Ldr Spine USA, Inc. · May 2017