Cleared Special

K121953 - HEMASORB APPLY

K121953 · Orthocon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
141d
Days
-
Risk

K121953 is an FDA 510(k) clearance for the HEMASORB APPLY. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on November 21, 2012 after a review of 141 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K121953

510(k) Number K121953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2012
Decision Date November 21, 2012
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
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 42
Devices cleared under the same product code (MTJ) and FDA review panel - the closest regulatory comparables to K121953.
AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY
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HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY
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ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY
K122156 · Orthocon, Inc. · Jan 2013
HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX
K111575 · Orthocon, Inc. · May 2012
HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
K113627 · Orthocon · Feb 2012
SYNTHES HEMOSTATIC BONE PUTTY
K113079 · Synthes (Usa) Products, LLC/Norian Corporation · Dec 2011
K121953 · HEMASORB APPLY
Download PDF FDA Summary Orthocon, Inc.