Cleared Traditional

K080399 - DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE

K080399 is an FDA 510(k) clearance for DBX DEMINERALIZED BONE MATRIX PUTTY, manufactured by Musculoskeletal Transplant Foundation. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K080399

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
Combination Product No
PCCP Authorized No
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.

MBP Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K080399.
CLEARED UNDER GRAFTON II EDBM
K122513 · Medtronic Sofamor Danek, Inc. · Mar 2013
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
K113728 · Hans Biomed Corp. · Nov 2012
ACCELL EVO3 (FORMERLY ACCELL A2I)
K103742 · Integra Life Sciences · Mar 2011
SYGNAL DBM
K080405 · Musculoskeletal Transplant Foundation · Aug 2008
CAP PLUS, EQUIVABONE, CAP/DBM
K080329 · Etex Corp. · Apr 2008
SYGNAL DBM
K073329 · Musculoskeletal Transplant Foundation · Feb 2008