Cleared Special

K072327 - CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON

K072327 is an FDA 510(k) clearance for CANCELLO-PURE BONE WEDGE, manufactured by Regeneration Technologies, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 65-day FDA review.

K072327 · Regeneration Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
65d
Days
Class 2
Risk

K072327 is an FDA 510(k) clearance for the CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Regeneration Technologies, Inc. (Alachua, US). The FDA issued a Cleared decision on October 24, 2007 after a review of 65 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 - K072327

510(k) Number K072327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2007
Decision Date October 24, 2007
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 K072327.
POLYGRAFT BGS
K062607 · Smith & Nephew, Inc. · Nov 2007
MASTERGRAFT PUTTY
K071813 · Medtronic Sofamor Danek · Nov 2007
APACERAM BONE GRAFT SUBSTITUTE
K071912 · Pentax Corp. · Oct 2007
SYNTHES CHRONOS COMPOSITE
K071046 · Synthes (Usa) · Oct 2007
A-BSM BONE SUBSTITUTE MATERIAL
K072636 · Etex Corp. · Oct 2007
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
K070751 · Isotis Orthobiologics, Inc. · Oct 2007
K072327 · CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
Download PDF FDA Summary Regeneration Technolo…