Cleared Special

K152005 - MONTAGE Settable

K152005 · Orthocon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
87d
Days
-
Risk

K152005 is an FDA 510(k) clearance for the MONTAGE Settable, Resorbable Hemostatic Bone Putty. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on October 15, 2015 after a review of 87 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 K152005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2015
Decision Date October 15, 2015
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 K152005.
HBP6 Settable, Resorbable Hemostatic Bone Paste
K193052 · Orthocon, Inc. · Mar 2020
MONTAGE-QS Settable, Resorbable Hemostatic Bone
K191140 · Orthocon, Inc. · Jul 2019
HEMASORBPLUS Resorbable Hemostatic Bone Putty
K153317 · Orthocon, Inc. · Nov 2016
HEMASORBPLUS press Resorable Hemostatic Bone Putty
K143069 · Orthocon, Inc. · Dec 2014
HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
K141502 · Orthocon, Inc. · Oct 2014
AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY
K140117 · Orthocon, Inc. · Feb 2014