510(k) Report

Devices descending from K041081

257 later devices reach Fragment Plate System, Screws, Pins and K-Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+4K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K200785Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc.20200—
+4K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+4K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K173746Activmotion RangeNewclip Technics20181—
+4K172008ARIX Humerus SystemJeil Medical Corporation20173—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K170705ARIX Wrist SystemJeil Medical Corporation20172—
+4K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K161746ARIX Hand SystemJeil Medical Corporation20161—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K141992Variax 2 SystemStryker Trauma AG201422—
+4K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+4K132502Variax 2 SystemStryker Trauma AG201321—
+4K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+4K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+4K101056Variax Elbow SystemHowmedica Osteonics Corp.201058—
+4K093433Variax Elbow System Plate Line ExtensionHowmedica Osteonics Corp.20101—
+4K092671Variax Elbow System Line ExtensionHowmedica Osteonics Corp.20090—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K230938ARIX Humerus SystemJeil Medical Corporation20230—
+5K230204ALPHALOK Plating SystemVilex, LLC20230—
+5K221558ALPHALOK Plating SystemVilex, LLC20222—
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K221395Footmotion Plating SystemNewclip Technics20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K170771VariAx 2 Foot SystemStryker GmbH20170—
+5K161448Footmotion Plating SystemNewclip Technics20165—
+5K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+5K151769Anchorage 2 CP SystemStryker GmbH20150—
+5K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+5K151407RECON systemNormed Medizin-Technik GmbH20154—
+5K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+5K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+5K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+5K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+5K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+5K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+5K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+6K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+6K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+6K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K200062Foot and Ankle SystemLeith Medical, LLC20210—
+6K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+6K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—