Cleared Special

K052913 - IGNITE BONE VOID FILLER KIT

K052913 is the FDA 510(k) clearance for IGNITE BONE VOID FILLER KIT by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code MQV) cleared through the Special 510(k) pathway after a 21-day FDA review.

K052913 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
21d
Days
Class 2
Risk

K052913 is an FDA 510(k) clearance for the IGNITE BONE VOID FILLER KIT. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on November 7, 2005 after a review of 21 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K052913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2005
Decision Date November 07, 2005
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 251
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K052913.
OSSIMEND (TM) BONE GRAFT MATERIAL
K052812 · Collagen Matrix, Inc. · Jan 2006
MASTERGRAFT PUTTY BONE VOID FILLER
K051386 · Medtronic Vascular · Dec 2005
TRICOS T
K051722 · Baxter Healthcare Corp · Nov 2005
NOVABONE-BIOACTIVE SYNTHETIC GRAFT
K052494 · Novabone Products, LLC · Nov 2005
INTERGRO DBM
K031399 · Interpore Cross Intl. · Feb 2005
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
K043308 · Depuy Spine, Inc. · Feb 2005