Cleared Special

CEM-OSTETIC BONE (K030266) - FDA 510(k) Clearance

Also marketed or referenced as:
CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030266 · Berkeley Advanced Biomaterials, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
24d
Days
Class 2
Risk

K030266 is an FDA 510(k) clearance for the CEM-OSTETIC BONE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Berkeley Advanced Biomaterials, Inc. (San Leandro, US). The FDA issued a Cleared decision on February 20, 2003 after a review of 24 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Berkeley Advanced Biomaterials, Inc. devices

Submission Details

510(k) Number K030266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2003
Decision Date February 20, 2003
Days to Decision 24 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 195
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K030266.
MIIG II BONE GRAFT SUBSTITUTE
K024336 · Wrightmedicaltechnologyinc · Mar 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K030178 · Biomet, Inc. · Feb 2003
JAX
K010555 · Smith & Nephew, Inc. · Feb 2003
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862 · Synthes (Usa) · Dec 2002
WMT-TCP BONE GRAFT SUBSTITUTE
K022629 · Wrightmedicaltechnologyinc · Nov 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531 · Biomet, Inc. · Sep 2002