Cleared Traditional

ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY (K122156) - FDA 510(k) Clearance

K122156 · Orthocon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 41
Devices cleared under the same product code (MTJ) and FDA review panel - the closest regulatory comparables to K122156.
Permatage Flowable, Settable Hemostatic Bone Paste
K261439 · Orthocon, Inc. · Jun 2026
Montage- XT Settable, Resorbable Hemostatic Bone Putty
K232998 · Orthocon, Inc. · Oct 2023
MONTAGE Settable, Resorbable Hemostatic Bone Putty
K213418 · Orthocon, Inc. · Aug 2023
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
K231386 · Orthocon, Inc. · Jul 2023
Meril-Bonewax
K200452 · M/s. Meril Endo Surgery Private Limited. · Mar 2023
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
K220315 · Orthocon, Inc. · Mar 2022