Cleared Special

K113627 - HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY

K113627 · Orthocon · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
71d
Days
-
Risk

K113627 is an FDA 510(k) clearance for the HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon (Irvington, US). The FDA issued a Cleared decision on February 17, 2012 after a review of 71 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 - K113627

510(k) Number K113627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2011
Decision Date February 17, 2012
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
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
Devices cleared under the same product code (MTJ) and FDA review panel - the closest regulatory comparables to K113627.
ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY
K122156 · Orthocon, Inc. · Jan 2013
HEMASORB APPLY
K121953 · Orthocon, Inc. · Nov 2012
HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX
K111575 · Orthocon, Inc. · May 2012
SYNTHES HEMOSTATIC BONE PUTTY
K113079 · Synthes (Usa) Products, LLC/Norian Corporation · Dec 2011
SKAFFOLD CIS
K111538 · Skeletal Kinetics, LLC · Oct 2011
MP 719
K111524 · Marine Polymer Technologies, Inc. · Jul 2011
K113627 · HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
Download PDF FDA Summary Orthocon