Cleared Traditional

K113791 - B-GENIN, R-GENIN

K113791 is an FDA 510(k) clearance for B-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 84-day FDA review.

K113791 · Berkeley Advanced Biomaterials, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
84d
Days
Class 2
Risk

K113791 is an FDA 510(k) clearance for the B-GENIN, 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 March 15, 2012 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K113791

510(k) Number K113791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2011
Decision Date March 15, 2012
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K113791.
KENSEY NASH BONE VOID FILLER XC
K120141 · Kensey Nash Cororation · May 2012
NANOFUSE DBM
K120279 · Nanotherapeutics · Apr 2012
APACERAM BONE GRAFT SUBSTITUTE
K120602 · Hoya Corporation · Mar 2012
POLYFUSE - NEUROBONE
K111018 · Atpac Medical, LLC · Feb 2012
CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
K112383 · Skeletal Kinetics, LLC · Feb 2012
MTF NEW BONE VOILD FILLER
K113167 · Musculoskeletal Transplant Foundation · Jan 2012
K113791 · B-GENIN, R-GENIN
Download PDF FDA Summary Berkeley Advanced Bio…