510(k) Report

Devices descending from K031961

21 later devices reach Inion Otps Biodegradable Mesh Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY201317—
+1K063410Inion CPS/Otps FreedomplateInion, Ltd.20072—
+2K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+2K203105Inion CompressOn ScrewInion OY20210—
+2K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+2K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+2K160304OsteoBullet Compression ScrewPhalanx Innovations20168—
+2K081588RE-Zorb Plating SystemAcute Innovations, LLC20081—
+3K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+3K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+3K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+3K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+3K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+3K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+3K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+3K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+3K120163Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC20120—
+4K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+4K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+4K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+4K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—