Cleared Special

K051914 - GENEROS 80, GENEROS 60

K051914 is an FDA 510(k) clearance for GENEROS 80, manufactured by Berkeley Advanced Biomaterials, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 112-day FDA review.

K051914 · Berkeley Advanced Biomaterials, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
112d
Days
Class 2
Risk

K051914 is an FDA 510(k) clearance for the GENEROS 80, GENEROS 60. 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 November 3, 2005 after a review of 112 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K051914

510(k) Number K051914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2005
Decision Date November 03, 2005
Days to Decision 112 days
Submission Type Special
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
10d faster than avg
Panel avg: 122d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

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 K051914.
MASTERGRAFT PUTTY BONE VOID FILLER
K051386 · Medtronic Vascular · Dec 2005
TRICOS T
K051722 · Baxter Healthcare Corp · Nov 2005
IGNITE BONE VOID FILLER KIT
K052913 · Wrightmedicaltechnologyinc · Nov 2005
NOVABONE-BIOACTIVE SYNTHETIC GRAFT
K052494 · Novabone Products, LLC · Nov 2005
MERRIES UNI-OSTEO, MODEL CS30250-CS10102
K051698 · Merries International, Inc. · Sep 2005
CERAMENT BONE VOID FILLER
K051951 · Bonesupport AB · Sep 2005
K051914 · GENEROS 80, GENEROS 60
Download PDF FDA Summary Berkeley Advanced Bio…