Cleared Traditional

K051195 - GRAFTON DBM

K051195 is an FDA 510(k) clearance for GRAFTON DBM, 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 220-day FDA review.

K051195 · Osteotech, Inc. · Orthopedic device
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Dec 2005
Decision
220d
Days
Class 2
Risk

K051195 is an FDA 510(k) clearance for the GRAFTON DBM. 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 16, 2005 after a review of 220 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 Osteotech, Inc. devices

FDA 510(k) Submission Details - K051195

510(k) Number K051195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2005
Decision Date December 16, 2005
Days to Decision 220 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
98d slower than avg
Panel avg: 122d · This submission: 220d
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 K051195.
OSTEOSET DBM PELLETS
K053642 · Wrightmedicaltechnologyinc · Jan 2006
DBX STRIP
K042829 · Musculoskeletal Transplant Foundation · Jan 2006
ALLOCRAFT DBM
K052735 · Lifecell Corp. · Dec 2005
VIAGRAF DBM PASTE
K043209 · Osteotech, Inc. · Dec 2005
ORTHOBLAST II PUTTY AND PASTE
K050642 · Isotis Orthobiologics, Inc. · Dec 2005
OPTIUM DBM GEL AND PUTTY
K053098 · Lifenet · Nov 2005