Cleared Traditional

K213418 - MONTAGE Settable, Resorbable Hemostatic Bone Putty (FDA 510(k) Clearance)

K213418 · Orthocon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
679d
Days
-
Risk

K213418 is an FDA 510(k) clearance for the MONTAGE 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 August 30, 2023 after a review of 679 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Orthocon, Inc. devices

Submission Details

510(k) Number K213418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2021
Decision Date August 30, 2023
Days to Decision 679 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
565d slower than avg
Panel avg: 114d · This submission: 679d
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 K213418.
Montage- XT Settable, Resorbable Hemostatic Bone Putty
K232998 · Orthocon, Inc. · Oct 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