Cleared Special

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. · Orthopedic

Oct 2025

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K253147 is an FDA 510(k) clearance for the 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, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Prosidyan, Inc. (New Providence, US). The FDA issued a Cleared decision on October 22, 2025, 27 days after receiving the submission on September 25, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K253147 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2025
Decision Date	October 22, 2025
Days to Decision	27 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF