Cleared Special

K142339 - HEMASORB Resorbable Hemostatic Bone Putty

K142339 · Orthocon, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
36d
Days
-
Risk

K142339 is an FDA 510(k) clearance for the HEMASORB Resorbable Hemostatic Bone Putty. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, LLC (Irvington, US). The FDA issued a Cleared decision on September 26, 2014 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 - K142339

510(k) Number K142339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2014
Decision Date September 26, 2014
Days to Decision 36 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

MTJ Device Classification - Class 0,

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 41
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K140117 · Orthocon, Inc. · Feb 2014
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K123243 · Orthocon, Inc. · Apr 2013
ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY
K122156 · Orthocon, Inc. · Jan 2013
K142339 · HEMASORB Resorbable Hemostatic Bone Putty
Download PDF FDA Summary Orthocon, LLC