Cleared Traditional

K123691 - MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTO...

K123691 is the FDA 510(k) clearance for MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTO... by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K123691 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Jan 2013
Decision
59d
Days
Class 2
Risk

K123691 is an FDA 510(k) clearance for the MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM). Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on January 31, 2013 after a review of 59 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Sofamor Danek, Inc. devices

Submission Details

510(k) Number K123691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2012
Decision Date January 31, 2013
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 233
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K123691.
KINEX BIOACTIVE
K130392 · Globus Medical, Inc. · Aug 2013
MASTERGRAFT STRIP
K130335 · Medtronic Sofamor Danek USA, Inc. · Apr 2013
PRO-DENSE BONE GRAFT SUBSTITUTE
K113871 · Wrightmedicaltechnologyinc · Mar 2013
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
K121989 · Exactech, Inc. · Nov 2012
FORTROSS BONE VOID FILLER
K110561 · Pioneer Surgical Technology · Apr 2011
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
K102722 · Synthes USA Products, LLC · Jan 2011