Cleared Traditional

MASTERGRAFT PUTTY BONE VOID FILLER (K051386) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K051386 · Medtronic Vascular · Orthopedic device
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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

Submission Details

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.

Device Classification

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 194
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K051386.
NORIAN SRS FAST SET PUTTY
K060406 · Synthes (Usa) · Mar 2006
ALLOMATRIX CUSTOM
K053319 · Wrightmedicaltechnologyinc · Mar 2006
MIIG SR
K060011 · Wrightmedicaltechnologyinc · Feb 2006
TRICOS T
K051722 · Baxter Healthcare Corp · Nov 2005
IGNITE BONE VOID FILLER KIT
K052913 · Wrightmedicaltechnologyinc · Nov 2005
SYNTHES (USA) CHRONOS
K043045 · Synthes (Usa) · Jan 2005