Cleared Traditional

PRODENSE Bone Graft Substitute

K181255 · Wrightmedicaltechnologyinc · Orthopedic
Sep 2018
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K181255 is an FDA 510(k) clearance for the PRODENSE Bone Graft Substitute, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on September 12, 2018, 124 days after receiving the submission on May 11, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K181255 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2018
Decision Date September 12, 2018
Days to Decision 124 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