Cleared Traditional

K122156 - ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY

K122156 · Orthocon, Inc. · General & Plastic Surgery device
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Jan 2013
Decision
192d
Days
-
Risk

K122156 is an FDA 510(k) clearance for the ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on January 28, 2013 after a review of 192 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Orthocon, Inc. devices

Submission Details

510(k) Number K122156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2012
Decision Date January 28, 2013
Days to Decision 192 days
Submission Type Traditional
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
77d slower than avg
Panel avg: 115d · This submission: 192d
Pathway characteristics
Predicate-based equivalence.

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 K122156.
HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
K141502 · Orthocon, Inc. · Oct 2014
AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY
K140117 · Orthocon, Inc. · Feb 2014
HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY
K123243 · Orthocon, Inc. · Apr 2013
HEMASORB APPLY
K121953 · Orthocon, Inc. · Nov 2012
HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX
K111575 · Orthocon, Inc. · May 2012
SYNTHES HEMOSTATIC BONE PUTTY (HBP)
K103822 · Synthes USA Products, LLC · May 2011