Cleared Traditional

K080399 - DBX DEMINERALIZED BONE MATRIX PUTTY

K080399 is the FDA 510(k) clearance for DBX DEMINERALIZED BONE MATRIX PUTTY by Musculoskeletal Transplant Foundation. It is a Class 2 Orthopedic device (product code MBP) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K080399 · Musculoskeletal Transplant Foundation · Orthopedic device
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Oct 2008
Decision
239d
Days
Class 2
Risk

K080399 is an FDA 510(k) clearance for the DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Musculoskeletal Transplant Foundation (Edison, US). The FDA issued a Cleared decision on October 10, 2008 after a review of 239 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 Musculoskeletal Transplant Foundation devices

Submission Details

510(k) Number K080399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2008
Decision Date October 10, 2008
Days to Decision 239 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 122d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
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 - MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

All 8
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K080399.
PliaFX Flo
K242799 · Lifenet Health · Nov 2024
CLEARED UNDER GRAFTON II EDBM
K122513 · Medtronic Sofamor Danek, Inc. · Mar 2013
OPTECURE
K063685 · Exactech, Inc. · Jun 2007
DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY
K061131 · Orthocon, Inc. · Feb 2007
PROGENIX DBM PUTTY AND PASTE
K060794 · Medtronic Sofamor Danek · Dec 2006
OPTECURE +CCC
K061668 · Exactech, Inc. · Sep 2006