Cleared Special

MODIFICATION TO ALLOMATRIX CUSTOM (K061939) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K061939 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
8d
Days
Class 2
Risk

K061939 is an FDA 510(k) clearance for the MODIFICATION TO ALLOMATRIX CUSTOM. 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 July 18, 2006 after a review of 8 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 K061939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2006
Decision Date July 18, 2006
Days to Decision 8 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
114d faster than avg
Panel avg: 122d · This submission: 8d
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 199
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K061939.
SYNTHES CHRONOS COMPOSITE
K071046 · Synthes (Usa) · Oct 2007
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
K072597 · Wrightmedicaltechnologyinc · Oct 2007
PRO-DENSE BONE VOID FILLER
K070437 · Wrightmedicaltechnologyinc · May 2007
NORIAN SRS BONE VOID FILLER
K060408 · Synthes (Usa) · Mar 2006
NORIAN SRS FAST SET PUTTY
K060406 · Synthes (Usa) · Mar 2006
ALLOMATRIX CUSTOM
K053319 · Wrightmedicaltechnologyinc · Mar 2006