Cleared Traditional

K020986 - MASTERGRAFT RESORBABLE CERAMIC

K020986 is an FDA 510(k) clearance for MASTERGRAFT RESORBABLE CERAMIC, 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 117-day FDA review.

K020986 · Medtronic Sofamor Danek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
117d
Days
Class 2
Risk

K020986 is an FDA 510(k) clearance for the MASTERGRAFT RESORBABLE CERAMIC. 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 July 22, 2002 after a review of 117 days - within the typical 510(k) review window.

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 - K020986

510(k) Number K020986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2002
Decision Date July 22, 2002
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
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 K020986.
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K021551 · Biocomposites, Ltd. · Nov 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531 · Biomet, Inc. · Sep 2002
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
K021336 · Novabone Products, LLC · Jul 2002
CALCIGEN-S BONE VOID FILER
K013790 · Biomet Orthopedics, Inc. · Jun 2002
CONDUIT TCP GRANULES
K014053 · Depuyacromed · Mar 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K012506 · Medtronic Sofamor Danek USA, Inc. · Mar 2002