Cleared Traditional

K231386 - Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste (FDA 510(k) Clearance)

K231386 · Orthocon, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2023
Decision
60d
Days
-
Risk

K231386 is an FDA 510(k) clearance for the Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, Inc. (Stamford, US). The FDA issued a Cleared decision on July 11, 2023 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Orthopedic 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthocon, Inc. devices

Submission Details

510(k) Number K231386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2023
Decision Date July 11, 2023
Days to Decision 60 days
Submission Type Traditional
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
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

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 K231386.
Montage- XT Settable, Resorbable Hemostatic Bone Putty
K232998 · Orthocon, Inc. · Oct 2023
MONTAGE Settable, Resorbable Hemostatic Bone Putty
K213418 · Orthocon, Inc. · Aug 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