Cleared Traditional

K123691 - MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)

K123691 is an FDA 510(k) clearance for MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTO..., manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K123691

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.

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 K123691.
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