Cleared Traditional

K051386 - MASTERGRAFT PUTTY BONE VOID FILLER

K051386 is an FDA 510(k) clearance for MASTERGRAFT PUTTY BONE VOID FILLER, manufactured by Medtronic Vascular. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K051386 · Medtronic Vascular · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
203d
Days
Class 2
Risk

K051386 is an FDA 510(k) clearance for the MASTERGRAFT PUTTY BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Medtronic Vascular (Memphis, US). The FDA issued a Cleared decision on December 16, 2005 after a review of 203 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 Vascular devices

FDA 510(k) Submission Details - K051386

510(k) Number K051386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2005
Decision Date December 16, 2005
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 436
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K051386.
OSSIMEND (TM) BONE GRAFT MATERIAL
K052812 · Collagen Matrix, Inc. · Jan 2006
MBCP
K051774 · Biomatlante · Jan 2006
STRYKER INJECTABLE CEMENT
K051603 · Stryker Leibinger Micro Implants · Dec 2005
TRICOS T
K051722 · Baxter Healthcare Corp · Nov 2005
IGNITE BONE VOID FILLER KIT
K052913 · Wrightmedicaltechnologyinc · Nov 2005
GENEROS 80, GENEROS 60
K051914 · Berkeley Advanced Biomaterials, Inc. · Nov 2005