510(k) Report

Devices descending from K964226

285 later devices reach Memory Staple (20 Sizes Available) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+1K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies200772—
+1K070031Memometal Memory StaplesMemometal Technologies2007114—
+1K060746Memory StapleDePuy Orthopaedics, Inc.200659—
+1K011716The Uni-Clip StapleNew Deal, S.A.20011171
+1K993714Memograph Staple, Warm SystemBiomedical Ent., Inc.2000222—
+1K991482Uni-Clip StapleNew Deal, S.A.1999119—
+2K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+2K192447Superelastic StapleNeosteo20200—
+2K191463DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC202002
+2K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC20190—
+2K172485Footmotion HammerToeNewclip Technics20180—
+2K173616DIP Arthrodesis SystemIn2bones Sas20180—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172052Arthrex DynaNite Nitinol StapleArthrex, Inc.20171—
+2K171473Compressyn™ StapleDallen Medical, Inc.20170—
+2K170326dynaMX Intramedullary ImplantArthrex, Inc.20172—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K160813EasyStepStryker GmbH20160—
+2K153622First Ray Internal Bone Staple SystemFirst Ray, LLC20164—
+2K153770OS2(R)-VP Varisation StapleIn2bones Sas20164—
+2K153395OS2-C Compression StapleIn2bones Sas20167—
+2K153129dynaMX Tabbed StapleMx Orthopedics, Corp.20162—
+2K150211EzFuze Implant SystemVilex IN Tennessee, Inc.20150—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K143622dynaMX Compression StapleMx Orthopedics, Corp.20153—
+2K143049LYNC intramedullary implantNovastep20150—
+2K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+2K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc.2014133
+2K142727CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems201481
+2K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140—
+2K142148Orthohelix Staple SystemOrthohelix Surgical Designs, Inc.20140—
+2K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+2K133844Speed TriadBiomedical Ent., Inc.20140—
+2K133477Toegrip, Implant for Proximal Inter-Phalangeal ArthrodesisSynchro Medical20149—
+2K133523Stapix Superelastic Implant Bone StaplesInstratek, Inc.20143—
+2K131640Smooth or Threaded Metallic Bone FastenerBiomedical Ent., Inc.20137—
+2K130832Orthohelix Staple SystemOrthohelix Surgical Designs, Inc.20131—
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K124045Fuseforce Implant SystemSolana Surgical, LLC201329—
+2K124022Speed ShiftBiomedical Enterprises, Inc.201320—
+2K123926Metasurg Nitinol Staple ImplantMetasurg20136—
+2K122113Memory Metal Staples, EasyclipStryker Corp.2013131
+2K122871Compressyn StapleDallen Medical, Inc.20134—
+2K112837Vilex EZ-Staple (Memory Bone Fixation Staple)Vilex, Inc.20125—
+2K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+2K120165Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.201235—
+2K103623Newdeal Interphalangeal ImplantNewdeal Sas20120—
+2K112197Memometal Intra-Medullary Bone FastenerMemometal Technologies201151
+2K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC2011166
+2K071477Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC20071—
+2K070688Nexfix Compression StapleNexa Orthopedics, Inc.20070—
+2K061594Large Uni-Clip StapleNew Deal, S.A.2006103—
+2K051408Intelifuse, Inc. Warm System with StimulinksIntelifuse, Inc.20056—
+2K023488Osstaple, CraniofacialBiomedical Enterprises, Inc.20020—
+2K023486Osstaple, MaxillofacialBiomedical Enterprises, Inc.20020—
+2K023203OsstapleBiomedical Ent., Inc.20020—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+3K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+3K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+3K232990A’TOMIC™ Nitinol Fixation SystemRmr Ortho, LLC20240—
+3K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K231493NITINEX Memory Compression StapleVilex, LLC20230—
+3K231458Extremity StapleRestor3D20230—
+3K221947Tyber Medical Staple Fixation System (various)Tyber Medical, LLC20220—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K210582EasyClip® and EasyClip® XpressStryker GmbH20221—
+3K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K203832FuseForce™ Flex Dynamic Compression SystemWright Medical202181
+3K210482Medline UNITE REFLEX Nitinol Staple SystemMedline Industries, Inc.20214—
+3K203180Arthrex DynaNite Nitinol StaplesArthrex, Inc.20201—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K201715Smart Toe II, X FuseStryker GmbH20201—
+3K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+3K193305DynaClip Bone StapleMedShape, Inc.20203—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+3K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+3K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc.20191—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K181781DynaClipTM Bone StapleMedShape, Inc.20182—
+3K181815DynaBridgeFusion Orthopedics, LLC20180—
+3K181866MotoCLIP/HiMAX Step Staple Implant SystemCrossroads Extremity Systems, LLC20180—
+3K181410MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC20186—
+3K173775Clench Compression StapleF & A Foundation, LLC D.B.A. Reign Medical20180—
+3K171703PUMA SystemPanther Orthopedics, Inc.20180—
+3K170688PIT’Stop® implantIn2bones Sas20171—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K162354Sniper Staple SystemTrilliant Surgical, Ltd.20175—
+3K162321EasyClip XpressRestore Surgical, LLC Dba Instratek20172—
+3K163440Stealth Staple SystemFirst Ray, LLC20173—
+3K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC201622