Cleared Special

K061939 - MODIFICATION TO ALLOMATRIX CUSTOM

K061939 is an FDA 510(k) clearance for MODIFICATION TO ALLOMATRIX CUSTOM, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 8-day FDA review.

K061939 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2006
Decision
8d
Days
Class 2
Risk

K061939 is an FDA 510(k) clearance for the MODIFICATION TO ALLOMATRIX CUSTOM. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 18, 2006 after a review of 8 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K061939

510(k) Number K061939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2006
Decision Date July 18, 2006
Days to Decision 8 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
114d faster than avg
Panel avg: 122d · This submission: 8d
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 444
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K061939.
HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM
K062495 · Depuy Spine, Inc. · Oct 2006
KENSEY NASH BONE VOID FILLER
K060917 · Kensey Nash Corporation · Sep 2006
ALLOGRAN-R
K061311 · Biocomposites, Ltd. · Sep 2006
BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM
K053213 · Berkeley Advanced Biomaterials, Inc. · Jul 2006
OSTEO-LINK BONE VOID FILLER PELLETS
K060809 · Promed Advance Technology Co., Ltd. · Jul 2006
BIO 1-KIT BIOSORB FILLED CARTRIDGE
K061022 · Science For Biomaterials · May 2006