Cleared Traditional

K082166 - MASTERGRAFT STRIP

K082166 is an FDA 510(k) clearance for MASTERGRAFT STRIP, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K082166 · Medtronic Sofamor Danek · Orthopedic device
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Jun 2009
Decision
306d
Days
Class 2
Risk

K082166 is an FDA 510(k) clearance for the MASTERGRAFT STRIP. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on June 2, 2009 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medtronic Sofamor Danek devices

FDA 510(k) Submission Details - K082166

510(k) Number K082166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2008
Decision Date June 02, 2009
Days to Decision 306 days
Submission Type Traditional
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
184d slower than avg
Panel avg: 122d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 425
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K082166.
EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE
K090855 · Etex Corp. · Sep 2009
WMT COMPOSITE DBM
K083270 · Wrightmedicaltechnologyinc · Aug 2009
E-MATRIX GRAFT BONE EXTENDER
K083449 · Pioneer Surgical Technology · Jun 2009
OSTEOCRETE BONE VOID FILLER
K071004 · Bone Solutions, Inc. · May 2009
NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD
K090731 · Novabone Products, LLC · Apr 2009
INTERGRO DBM
K082793 · Biomet Spine · Apr 2009