510(k) Report

Devices descending from K060478

27 later devices reach Arthrex Bio-Compression Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+1K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+1K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+2K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+2K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+2K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+2K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+2K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+2K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+2K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+2K162171S4 Screw System™Subchondral Solutions20173—
+2K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+2K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+2K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+2K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+3K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+3K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+3K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+3K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+3K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+3K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+3K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+3K210159IntraLock SystemFusion Orthopedics, LLC20210—
+3K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+3K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—