510(k) Report

Devices descending from K972323

42 later devices reach Osteo Bos System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+1K133440Axsos 3 TI Locking Plate System Line ExtensionStryker Trauma AG201312—
+1K123964Axsos 3 TI Locking Plate SystemStryker Trauma AG201319—
+1K023360Leforte System Bone PlateJeil Medical Corporation200220—
+2K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+2K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+2K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+2K131311Arix Foot SystemJeil Medical Corporation20139—
+2K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+3K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+3K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K170697GBR systemSurgident20182—
+3K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+3K161864ARIX Foot SystemJeil Medical Corporation20165—
+3K143730GBR SystemJeil Medical Corporation20152—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K222367Save GBRDentis Co., Ltd.20230—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—