510(k) Report

Devices descending from K043059

207 later devices reach Compression Staple and Simple Staple through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173693Orbitum Bone Staple Implant, X and VIOrthovestments, LLC20180—
+1K172052Arthrex DynaNite Nitinol StapleArthrex, Inc.20171—
+1K163226EPIC Extremely Small StapleEpic Extremely, LLC20171—
+1K122871Compressyn StapleDallen Medical, Inc.20134—
+1K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG201224—
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+1K102387Mediscope Compressiopn Staple and AccessoriesMediscope Manufacturing, Inc.20110—
+1K080111Arthrex Compression StapleArthrex, Inc.20089—
+1K070688Nexfix Compression StapleNexa Orthopedics, Inc.20070—
+1K051908Charlotte Compression PlateWrightmedicaltechnologyinc2005149—
+2K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+2K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+2K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts20234—
+2K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226—
+2K180544DePuy Synthes Static StaplesSynthes (USA) Products, LLC20180—
+2K172205ExoToe StapleExotoe, LLC20180—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161303dynaMX™ Compression PlateMx Orthopedics, Corp.20171—
+2K151160Arcus Staple SystemNextremity Solutions, Inc.20151—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+2K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+2K140358Compressyn StapleDallen Medical, Inc.20142—
+2K132875Compressyn StapleDallen Medical, Inc.20133—
+2K130510Arthrex Compression PlatesArthrex, Inc.20138—
+2K131061Restore Bunion Correction SystemNextremity Solutions201315—
+2K130627Swing-Off ScrewAdvanced Interventional Technology, LLC20130—
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+2K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+2K092528Biomet Forerunner Locking Plate SystemBiomet Trauma (Aka Ebi, Lp)201053—
+2K070447Newdeal Compression PlateNewdeal Sas20071022
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+3K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+3K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K210456Ligament StapleMedacta International S.A.20210—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+3K193345Arthrex DynaNite Compression PlateArthrex, Inc.20200—
+3K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K171473Compressyn™ StapleDallen Medical, Inc.20170—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+3K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+3K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+3K093914Newdeal Compression PlatesNewdeal Sas2011985
+3K091609Newdeal Compression PlateNewdeal Sas200921
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K161448Footmotion Plating SystemNewclip Technics20165—
+4K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+4K153379AxSOS 3TiStryker GmbH201625—
+4K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+4K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+4K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+4K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+4K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+4K141905Pro-Link Wedge SystemLife Spine201411—