Cleared Special

K153608 - Vitoss BiModal Bone Graft Substitute Fo...

K153608 is an FDA 510(k) clearance for Vitoss BiModal Bone Graft Substitute Fo..., manufactured by Orthovita, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 57-day FDA review.

K153608 · Orthovita, Inc. · Orthopedic device
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Feb 2016
Decision
57d
Days
Class 2
Risk

K153608 is an FDA 510(k) clearance for the Vitoss BiModal Bone Graft Substitute Foam Strip. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Orthovita, Inc. (Malver, US). The FDA issued a Cleared decision on February 12, 2016 after a review of 57 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.

View all Orthovita, Inc. devices

FDA 510(k) Submission Details - K153608

510(k) Number K153608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2015
Decision Date February 12, 2016
Days to Decision 57 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 122d · This submission: 57d
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 Peers - MQV Filler, Bone Void, Calcium Compound

All 263
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