510(k) Report

Devices descending from K181180

13 later devices reach OSSIO™ Pin Product Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies20253—
+1K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+1K211789restor3d Pin ImplantsRestor3D20220—
+1K203465OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail…OSSIO, Ltd.20215—
+1K190652OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO, Ltd.20201—
+2K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+2K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+2K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+2K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+2K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+2K230750OSSIOfiber® Cannulated Trimmable Fixation NailOSSIO, Ltd.20234—
+2K201803OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO, Ltd.20200—
+3K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—