Cleared Special

K143549 - Vivorte Trabexus

K143549 is an FDA 510(k) clearance for Vivorte Trabexus, manufactured by Vivorte, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 30-day FDA review.

K143549 · Vivorte, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
30d
Days
Class 2
Risk

K143549 is an FDA 510(k) clearance for the Vivorte Trabexus. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Vivorte, Inc. (Louisville, US). The FDA issued a Cleared decision on January 14, 2015 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K143549

510(k) Number K143549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2014
Decision Date January 14, 2015
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MQV Device Classification - Class 2, Special Controls

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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

Peoples & Associates
STEPHEN J. PEOPLES

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 - MQV Filler, Bone Void, Calcium Compound

All 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K143549.
NANOFUSE DBM
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MCS Bone Graft
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osteoSPAN Morpheus
K142828 · Biogennix · Jan 2015
Bio2 CLM BG Bioactive Scaffold
K142463 · Bio2 Technologies, Inc. · Dec 2014
NOVABONE BIOACTIVE STRIP
K141207 · Novabone Products, LLC · Oct 2014
REBOSSIS
K142090 · Orthorebirth Co., Ltd. · Oct 2014
K143549 · Vivorte Trabexus
Download PDF FDA Summary Vivorte, Inc.