Cleared Traditional

Montage-XT Settable, Resorbable Bone Putty

K233566 · Orthocon, Inc. · Orthopedic
Aug 2024
Decision
289d
Days
Class 2
Risk

About This 510(k) Submission

K233566 is an FDA 510(k) clearance for the Montage-XT Settable, Resorbable Bone Putty, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Orthocon, Inc. (Stamford, US). The FDA issued a Cleared decision on August 21, 2024, 289 days after receiving the submission on November 6, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K233566 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2023
Decision Date August 21, 2024
Days to Decision 289 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

Similar Devices — MQV Filler, Bone Void, Calcium Compound

All 488
Adaptos?Fuse Bone Graft
K253524 · Biomendex OY · Feb 2026
FIBERGRAFT? BG Putty GPS Bone Graft Substitute FIBERGRAFT? BG Putty Bone Graft Substitute FIBERGRAFT? AERIDYAN? Matrix Bone Graft Substitute FIBERGRAFT? BG Matrix Bone Graft Substitute
K253147 · Prosidyan, Inc. · Oct 2025
Mg OSTEOINJECT?; Mg OSTEOREVIVE?; Mg OSTEOCRETE?
K251522 · Bone Solutions, Inc. · Oct 2025
Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)
K252085 · Wright Medical Technology, Inc. (Stryker Corporation) · Sep 2025
Device 300423 Granules
K251556 · Geistlich Pharma AG · Jul 2025
OsteoFlo HydroFiber
K251720 · SurGenTec, LLC · Jul 2025