Cleared Traditional

K012506 - MASTERGRAFT RESORBABLE CERAMIC GRANULES

K012506 is an FDA 510(k) clearance for MASTERGRAFT RESORBABLE CERAMIC GRANULES, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K012506 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
213d
Days
Class 2
Risk

K012506 is an FDA 510(k) clearance for the MASTERGRAFT RESORBABLE CERAMIC GRANULES. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on March 7, 2002 after a review of 213 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 USA, Inc. devices

FDA 510(k) Submission Details - K012506

510(k) Number K012506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date March 07, 2002
Days to Decision 213 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
91d slower than avg
Panel avg: 122d · This submission: 213d
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 K012506.
MASTERGRAFT RESORBABLE CERAMIC
K020986 · Medtronic Sofamor Danek, Inc. · Jul 2002
CALCIGEN-S BONE VOID FILER
K013790 · Biomet Orthopedics, Inc. · Jun 2002
CONDUIT TCP GRANULES
K014053 · Depuyacromed · Mar 2002
NORIAN SRS BONE VOID FILLER
K011897 · Synthes (Usa) · Dec 2001
BSM BONE SUBSTITUTE MATERIAL
K011048 · DePuy Orthopaedics, Inc. · Nov 2001
OSTEOSET BVF KIT
K010532 · Wrightmedicaltechnologyinc · Oct 2001