Cleared Special

K071237 - COPIOS BONE VOID FILLER SPONGE AND PASTE

K071237 is an FDA 510(k) clearance for COPIOS BONE VOID FILLER SPONGE AND PASTE, manufactured by Kensey Nash Corp.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 29-day FDA review.

K071237 · Kensey Nash Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
29d
Days
Class 2
Risk

K071237 is an FDA 510(k) clearance for the COPIOS BONE VOID FILLER SPONGE AND PASTE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Kensey Nash Corp. (Exton, US). The FDA issued a Cleared decision on June 1, 2007 after a review of 29 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 - K071237

510(k) Number K071237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2007
Decision Date June 01, 2007
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 K071237.
MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER
K071155 · Science For Biomaterials · Jul 2007
OSSIPRO BONE SUBSTITUTE MATERIAL
K062630 · Etex Corp. · Jun 2007
BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER
K070864 · Biomet Osteobiologics · Jun 2007
ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
K071206 · Apatech , Ltd. · May 2007
PRO-DENSE BONE VOID FILLER
K070437 · Wrightmedicaltechnologyinc · May 2007
PRO OSTEON 500R
K063346 · Ebi, L.P. · Apr 2007