Cleared Traditional

K130703 - VIVORTE BVF

K130703 is an FDA 510(k) clearance for VIVORTE BVF, manufactured by Vivorte, Inc.. The device is a Class 2 Orthopedic device with product code MBP cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K130703 · Vivorte, Inc. · Orthopedic device
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Sep 2013
Decision
181d
Days
Class 2
Risk

K130703 is an FDA 510(k) clearance for the VIVORTE BVF. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Vivorte, Inc. (Fort Wayne, US). The FDA issued a Cleared decision on September 12, 2013 after a review of 181 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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 Vivorte, Inc. devices

FDA 510(k) Submission Details - K130703

510(k) Number K130703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2013
Decision Date September 12, 2013
Days to Decision 181 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 122d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBP Device Classification - Class 2, Special Controls

Product Code MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
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 Peers - MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

All 20
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K130703.
PliaFX Flo
K242799 · Lifenet Health · Nov 2024
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K122513 · Medtronic Sofamor Danek, Inc. · Mar 2013
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K080399 · Musculoskeletal Transplant Foundation · Oct 2008
SYGNAL DBM
K080405 · Musculoskeletal Transplant Foundation · Aug 2008
CAP PLUS, EQUIVABONE, CAP/DBM
K080329 · Etex Corp. · Apr 2008
SYGNAL DBM
K073329 · Musculoskeletal Transplant Foundation · Feb 2008