Cleared Special

K072355 - OSSIFUSE BONE SUBSTITUTE MATERIAL

K072355 is an FDA 510(k) clearance for OSSIFUSE BONE SUBSTITUTE MATERIAL, manufactured by Etex Corp.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 35-day FDA review.

K072355 · Etex Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
35d
Days
Class 2
Risk

K072355 is an FDA 510(k) clearance for the OSSIFUSE BONE SUBSTITUTE MATERIAL. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Etex Corp. (Cambridge, US). The FDA issued a Cleared decision on September 26, 2007 after a review of 35 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 - K072355

510(k) Number K072355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2007
Decision Date September 26, 2007
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
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 K072355.
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
K070751 · Isotis Orthobiologics, Inc. · Oct 2007
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
K072597 · Wrightmedicaltechnologyinc · Oct 2007
INION BIORESTORE
K070998 · Inion OY · Oct 2007
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
K072384 · Kensey Nash Corp. · Sep 2007
VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
K072184 · Orthovita, Inc. · Sep 2007
BONEMEDIK, AND BONEMEDIK-S
K070897 · Meta Biomed Co., Ltd. · Sep 2007