Cleared Traditional

K043209 - VIAGRAF DBM PASTE

K043209 is an FDA 510(k) clearance for VIAGRAF DBM PASTE, manufactured by Osteotech, Inc.. The device is a Class 2 Orthopedic device with product code MBP cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K043209 · Osteotech, Inc. · Orthopedic device
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Dec 2005
Decision
381d
Days
Class 2
Risk

K043209 is an FDA 510(k) clearance for the VIAGRAF DBM PASTE. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Osteotech, Inc. (Eatontown, US). The FDA issued a Cleared decision on December 5, 2005 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Osteotech, Inc. devices

FDA 510(k) Submission Details - K043209

510(k) Number K043209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2004
Decision Date December 05, 2005
Days to Decision 381 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
259d slower than avg
Panel avg: 122d · This submission: 381d
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 28
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K043209.
DBX STRIP
K042829 · Musculoskeletal Transplant Foundation · Jan 2006
ALLOCRAFT DBM
K052735 · Lifecell Corp. · Dec 2005
GRAFTON DBM
K051195 · Osteotech, Inc. · Dec 2005
ORTHOBLAST II PUTTY AND PASTE
K050642 · Isotis Orthobiologics, Inc. · Dec 2005
OPTIUM DBM GEL AND PUTTY
K053098 · Lifenet · Nov 2005
GRAFTON PLUS DBM PASTE
K043048 · Osteotech, Inc. · Nov 2005