510(k) Report

Devices descending from K021164

26 later devices reach Macropore OS Trauma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033918Ebi Lactosorb Graft Containment SystemEbi, L.P.20043—
+1K031961Inion Otps Biodegradable Mesh Plating SystemInion, Ltd.200421—
+2K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY201317—
+2K073115OrthomeshSynthes (Usa)20081—
+2K063410Inion CPS/Otps FreedomplateInion, Ltd.20072—
+2K052041Collagen Bone Healing Protective SheetCollagen Matrix, Inc.20050—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K203105Inion CompressOn ScrewInion OY20210—
+3K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+3K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+3K180821TruMatch Graft Cage - Long BoneSynthes (Usa), LLC20180—
+3K160304OsteoBullet Compression ScrewPhalanx Innovations20168—
+3K081588RE-Zorb Plating SystemAcute Innovations, LLC20081—
+4K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+4K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+4K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+4K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+4K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+4K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+4K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+4K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+4K120163Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC20120—
+5K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+5K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+5K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+5K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—