Cleared Traditional

Adaptos?Fuse Bone Graft

K253524 · Biomendex OY · Orthopedic
Feb 2026
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K253524 is an FDA 510(k) clearance for the Adaptos?Fuse Bone Graft, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Biomendex OY (Tampere, FI). The FDA issued a Cleared decision on February 17, 2026, 96 days after receiving the submission on November 13, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K253524 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2025
Decision Date February 17, 2026
Days to Decision 96 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
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
Grafton? DBM; Grafton Plus? DBM Paste; Magnifuse? Bone Graft
K251193 · Medtronic Sofamor Danek, Inc. · Jun 2025