Cleared Special

K091121 - ORTHOSTAT

K091121 · Orthocon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
11d
Days
-
Risk

K091121 is an FDA 510(k) clearance for the ORTHOSTAT. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, Inc. (North Brunswick, US). The FDA issued a Cleared decision on April 28, 2009 after a review of 11 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 K091121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2009
Decision Date April 28, 2009
Days to Decision 11 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
104d faster than avg
Panel avg: 115d · This submission: 11d
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 K091121.
HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX
K111575 · Orthocon, Inc. · May 2012
SYNTHES HEMOSTATIC BONE PUTTY (HBP)
K103822 · Synthes USA Products, LLC · May 2011
ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR
K102762 · Orthocon, Inc. · Feb 2011
ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
K063330 · Orthocon, Inc. · Nov 2006
AESCULAP BONE WAX
K000021 · Aesculap, Inc. · Mar 2000
AUTO SUTURE BONE WAX
K971680 · United States Surgical, A Division of Tyco Healthc · Oct 1997