Cleared Special

K091302 - INTEGRA MOZAIK AND OS MOLDABLE MORSELS

K091302 is an FDA 510(k) clearance for INTEGRA MOZAIK AND OS MOLDABLE MORSELS, manufactured by Integra LifeSciences Corporation. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 214-day FDA review.

K091302 · Integra LifeSciences Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
214d
Days
Class 2
Risk

K091302 is an FDA 510(k) clearance for the INTEGRA MOZAIK AND OS MOLDABLE MORSELS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on December 4, 2009 after a review of 214 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. 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. Standard predicate reliance. 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 - K091302

510(k) Number K091302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2009
Decision Date December 04, 2009
Days to Decision 214 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 slower than avg
Panel avg: 122d · This submission: 214d
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 K091302.
A-GRIX RESORBABLE BONE VOID FILLER
K091688 · Ag Digital Technology Corp. · Mar 2010
CARRIGEN
K093447 · Etex Corp. · Feb 2010
ORTHOSS
K090401 · Ed. Geistlich Soehne AG Fur Chemische Industrie · Jan 2010
DUOWEDGE SYNTHETIC BONE SUBSTITUTE
K073214 · Kasios · Dec 2009
PIONEER SURGICAL NANOSS BVF-E
K091031 · Pioneer Surgical Technology · Nov 2009
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
K091607 · Etex Corp. · Nov 2009
K091302 · INTEGRA MOZAIK AND OS MOLDABLE MORSELS
Download PDF FDA Summary Integra LifeSciences …