Cleared Traditional

K122513 - CLEARED UNDER GRAFTON II EDBM

K122513 is an FDA 510(k) clearance for CLEARED UNDER GRAFTON II EDBM, manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code MBP cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K122513 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Mar 2013
Decision
201d
Days
Class 2
Risk

K122513 is an FDA 510(k) clearance for the CLEARED UNDER GRAFTON II EDBM. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on March 6, 2013 after a review of 201 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. 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. Standard predicate reliance. 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, Inc. devices

FDA 510(k) Submission Details - K122513

510(k) Number K122513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2012
Decision Date March 06, 2013
Days to Decision 201 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
79d slower than avg
Panel avg: 122d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBP Device Classification - Class 2, Special Controls

Product Code MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
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 - MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

All 28
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K122513.
Vivorte Trabexus EB
K143547 · Vivorte, Inc. · Jan 2015
VIVORTE BVF
K130703 · Vivorte, Inc. · Sep 2013
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
K130498 · Bacterin International, Inc. · May 2013
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
K113728 · Hans Biomed Corp. · Nov 2012
ACCELL EVO3 (FORMERLY ACCELL A2I)
K103742 · Integra Life Sciences · Mar 2011
DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE
K080399 · Musculoskeletal Transplant Foundation · Oct 2008