Cleared Special

K232998 - Montage- XT Settable, Resorbable Hemostatic Bone Putty (FDA 510(k) Clearance)

K232998 · Orthocon, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2023
Decision
20d
Days
-
Risk

K232998 is an FDA 510(k) clearance for the Montage- XT Settable, Resorbable Hemostatic Bone Putty. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, Inc. (Stamford, US). The FDA issued a Cleared decision on October 12, 2023 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Orthopedic 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 K232998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2023
Decision Date October 12, 2023
Days to Decision 20 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 40
Devices cleared under the same product code (MTJ) and FDA review panel - the closest regulatory comparables to K232998.
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
HBP7 Settable Hemostatic Bone Putty
K202363 · Orthocon, Inc. · Jan 2021