Cleared Traditional

K072265 - PROGENIX DMB PUTTY

K072265 is an FDA 510(k) clearance for PROGENIX DMB PUTTY, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K072265 · Medtronic Sofamor Danek · Orthopedic device
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Jan 2008
Decision
147d
Days
Class 2
Risk

K072265 is an FDA 510(k) clearance for the PROGENIX DMB PUTTY. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on January 9, 2008 after a review of 147 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 devices

FDA 510(k) Submission Details - K072265

510(k) Number K072265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2007
Decision Date January 09, 2008
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
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 K072265.
MERRIES K-PHATE BONE GRAFT SUBSTITUTE
K063157 · Merries International, Inc. · Mar 2008
PLEXUR M
K073405 · Osteotech, Inc. · Mar 2008
BONALIVE GRANULES
K071199 · Vivoxid , Ltd. · Feb 2008
MICROFUSE BONE VOID FILLER
K071187 · Globus Medical, Inc. · Dec 2007
CROSS.BONE
K071876 · TriMed, Inc. · Dec 2007
CAP PLUS
K063050 · Etex Corp. · Nov 2007