Cleared Traditional

K091912 - B-GENIN AND R-GENIN

K091912 is an FDA 510(k) clearance for B-GENIN AND R-GENIN, manufactured by Berkeley Advanced Biomaterials, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K091912 · Berkeley Advanced Biomaterials, Inc. · Orthopedic device
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Jun 2010
Decision
363d
Days
Class 2
Risk

K091912 is an FDA 510(k) clearance for the B-GENIN AND R-GENIN. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Berkeley Advanced Biomaterials, Inc. (Berkeley, US). The FDA issued a Cleared decision on June 23, 2010 after a review of 363 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 Berkeley Advanced Biomaterials, Inc. devices

FDA 510(k) Submission Details - K091912

510(k) Number K091912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2009
Decision Date June 23, 2010
Days to Decision 363 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
241d slower than avg
Panel avg: 122d · This submission: 363d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQV Device Classification - Class 2, Special Controls

Product Code MQV Filler, Bone Void, Calcium Compound
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 - MQV Filler, Bone Void, Calcium Compound

All 308
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K091912.
FM-02 BONE GRAFT SUBSTITUTE
K102545 · Orthovita, Inc. · Oct 2010
NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT
K101860 · Novabone Products, LLC · Sep 2010
GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
K101557 · Etex Corp. · Jul 2010
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K092608 · Collagen Matrix, Inc. · May 2010
NANOSS BONE VOID FILLER
K100361 · Pioneer Surgical Technology · Apr 2010
CARRIGEN
K093447 · Etex Corp. · Feb 2010