Cleared Traditional

K130498 - OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130498 · Bacterin International, Inc. · Orthopedic device
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May 2013
Decision
94d
Days
Class 2
Risk

K130498 is an FDA 510(k) clearance for the OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Bacterin International, Inc. (Belgrade, US). The FDA issued a Cleared decision on May 31, 2013 after a review of 94 days - within the typical 510(k) review window.

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 Bacterin International, Inc. devices

Submission Details

510(k) Number K130498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2013
Decision Date May 31, 2013
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
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.