Cleared Special

K140117 - AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY

K140117 · Orthocon, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 2014
Decision
26d
Days
-
Risk

K140117 is an FDA 510(k) clearance for the AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on February 11, 2014 after a review of 26 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.

View all Orthocon, Inc. devices

Submission Details

510(k) Number K140117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2014
Decision Date February 11, 2014
Days to Decision 26 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
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 23
Devices cleared under the same product code (MTJ) and FDA review panel - the closest regulatory comparables to K140117.
MONTAGE Settable, Resorbable Hemostatic Bone Putty
K152005 · Orthocon, Inc. · Oct 2015
HEMASORBPLUS press Resorable Hemostatic Bone Putty
K143069 · Orthocon, Inc. · Dec 2014
HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
K141502 · Orthocon, Inc. · Oct 2014
HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY
K123243 · Orthocon, Inc. · Apr 2013
ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY
K122156 · Orthocon, Inc. · Jan 2013
HEMASORB APPLY
K121953 · Orthocon, Inc. · Nov 2012