Cleared Traditional

K220315 - MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty (FDA 510(k) Clearance)

K220315 · Orthocon, Inc. · Orthopedic device
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Mar 2022
Decision
36d
Days
-
Risk

K220315 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. (Irvington, US). The FDA issued a Cleared decision on March 11, 2022 after a review of 36 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 K220315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2022
Decision Date March 11, 2022
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
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 K220315.
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
HBP7 Settable Hemostatic Bone Putty
K202363 · Orthocon, Inc. · Jan 2021