Cleared Traditional

K063676 - DBX DEMINERALIZED BONE MATRIX MIX

K063676 is the FDA 510(k) clearance for DBX DEMINERALIZED BONE MATRIX MIX by Musculoskeletal Transplant Foundation. It is a Class 2 Orthopedic device (product code MBP) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K063676 · Musculoskeletal Transplant Foundation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
84d
Days
Class 2
Risk

K063676 is an FDA 510(k) clearance for the DBX DEMINERALIZED BONE MATRIX MIX. 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 March 5, 2007 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Musculoskeletal Transplant Foundation devices

Submission Details

510(k) Number K063676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2006
Decision Date March 05, 2007
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 K063676.
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