Cleared Special

K092046 - BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY

K092046 is an FDA 510(k) clearance for BI-OSTETIC FOAM AND PUTTY, 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 261-day FDA review.

K092046 · 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 2010
Decision
261d
Days
Class 2
Risk

K092046 is an FDA 510(k) clearance for the BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY. 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 24, 2010 after a review of 261 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. 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 - K092046

510(k) Number K092046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date March 24, 2010
Days to Decision 261 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
139d slower than avg
Panel avg: 122d · This submission: 261d
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 Consultant

Alexigen Biotech, LLC
Jacob Chandler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K092046.
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K092608 · Collagen Matrix, Inc. · May 2010
GRAFTY QUICKSET
K093343 · Graftys · Apr 2010
NANOSS BONE VOID FILLER
K100361 · Pioneer Surgical Technology · Apr 2010
A-GRIX RESORBABLE BONE VOID FILLER
K091688 · Ag Digital Technology Corp. · Mar 2010
CARRIGEN
K093447 · Etex Corp. · Feb 2010
ORTHOSS
K090401 · Ed. Geistlich Soehne AG Fur Chemische Industrie · Jan 2010
K092046 · BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY
Download PDF FDA Summary Berkeley Advanced Bio…