Cleared Special

K031651 - MODIFICATION TO CERASORB ORTHO

K031651 is an FDA 510(k) clearance for MODIFICATION TO CERASORB ORTHO, manufactured by Curasan AG. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 77-day FDA review.

K031651 · Curasan AG · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
77d
Days
Class 2
Risk

K031651 is an FDA 510(k) clearance for the MODIFICATION TO CERASORB ORTHO. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Curasan AG (Kleinostheim, DE). The FDA issued a Cleared decision on August 13, 2003 after a review of 77 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.

FDA 510(k) Submission Details - K031651

510(k) Number K031651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2003
Decision Date August 13, 2003
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 K031651.
VITOSS-FILLED CARTRIDGE
K032130 · Orthovita, Inc. · Nov 2003
PROFUSION BONE VOID FILLER KIT
K031838 · Biogeneration · Oct 2003
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K032409 · Orthovita, Inc. · Aug 2003
BONESOURCE BVF
K031435 · Howmedica Osteonics · Aug 2003
THERIFIL BONE FILLER
K031040 · Therics, Inc. · Jul 2003
POLYGRAFT BONE GRAFT SUBSTITUTE
K030288 · Osteobiologics, Inc. · Jul 2003
K031651 · MODIFICATION TO CERASORB ORTHO
Download PDF FDA Summary Curasan AG