Cleared Special

K141841 - INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP

K141841 is an FDA 510(k) clearance for INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD..., manufactured by Integra Lifescience Corportation. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 24-day FDA review.

K141841 · Integra Lifescience Corportation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
24d
Days
Class 2
Risk

K141841 is an FDA 510(k) clearance for the INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Integra Lifescience Corportation (Planisboro, US). The FDA issued a Cleared decision on August 1, 2014 after a review of 24 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 - K141841

510(k) Number K141841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2014
Decision Date August 01, 2014
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K141841.
FIBERGRAFT BG MORSELS
K141956 · Prosidyan, Inc. · Aug 2014
SKAFFOLD NMX BONE VOID FILLER
K132211 · Skeletal Kinetics, LLC · Aug 2014
AS20 COMPOSITE GRAFT
K141746 · Wrightmedicaltechnologyinc · Aug 2014
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
K140844 · Synergy Biomedical, Inc. · Jul 2014
SOLUM IV BONE VOID FILLER
K132470 · Spinesmith Partners, Llp · May 2014
OSTEOSPAN MORPHEUS
K132377 · Biogennix, LLC · May 2014
K141841 · INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP
Download PDF FDA Summary Integra Lifescience C…