510(k) Report

Devices descending from K902307

226 later devices reach Shaw II Hemostatic Surgery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993714Memograph Staple, Warm SystemBiomedical Ent., Inc.2000222—
+1K990728Thermal Cautery Device, ForcepsStarion Instruments19992—
+2K191463DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC202002
+2K172052Arthrex DynaNite Nitinol StapleArthrex, Inc.20171—
+2K160813EasyStepStryker GmbH20160—
+2K153129dynaMX Tabbed StapleMx Orthopedics, Corp.20162—
+2K143622dynaMX Compression StapleMx Orthopedics, Corp.20153—
+2K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc.2014133
+2K142148Orthohelix Staple SystemOrthohelix Surgical Designs, Inc.20140—
+2K130832Orthohelix Staple SystemOrthohelix Surgical Designs, Inc.20131—
+2K124022Speed ShiftBiomedical Enterprises, Inc.201320—
+2K123926Metasurg Nitinol Staple ImplantMetasurg20136—
+2K122871Compressyn StapleDallen Medical, Inc.20134—
+2K071477Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC20071—
+2K070031Memometal Memory StaplesMemometal Technologies2007114—
+2K051408Intelifuse, Inc. Warm System with StimulinksIntelifuse, Inc.20056—
+2K023488Osstaple, CraniofacialBiomedical Enterprises, Inc.20020—
+2K023486Osstaple, MaxillofacialBiomedical Enterprises, Inc.20020—
+2K023203OsstapleBiomedical Ent., Inc.20020—
+2K011716The Uni-Clip StapleNew Deal, S.A.20011171
+2K994019Cautery Grasper/DissectorStarion Instruments20000—
+2K992460Cautery Clamp and Battery Pack Power SupplyStarion Instruments19990—
+3K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+3K232990A’TOMIC™ Nitinol Fixation SystemRmr Ortho, LLC20240—
+3K231458Extremity StapleRestor3D20230—
+3K221947Tyber Medical Staple Fixation System (various)Tyber Medical, LLC20220—
+3K203180Arthrex DynaNite Nitinol StaplesArthrex, Inc.20201—
+3K193305DynaClip Bone StapleMedShape, Inc.20203—
+3K192447Superelastic StapleNeosteo20200—
+3K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC20190—
+3K181815DynaBridgeFusion Orthopedics, LLC20180—
+3K181866MotoCLIP/HiMAX Step Staple Implant SystemCrossroads Extremity Systems, LLC20180—
+3K173775Clench Compression StapleF & A Foundation, LLC D.B.A. Reign Medical20180—
+3K162354Sniper Staple SystemTrilliant Surgical, Ltd.20175—
+3K153622First Ray Internal Bone Staple SystemFirst Ray, LLC20164—
+3K153770OS2(R)-VP Varisation StapleIn2bones Sas20164—
+3K153395OS2-C Compression StapleIn2bones Sas20167—
+3K151615TiTHON Staple with OsseoTi TechnologyBiomet Manufacturing Corp20150—
+3K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+3K142727CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems201481
+3K141550Instafix Shape Memory Fixation SystemOt Medical20140—
+3K140358Compressyn StapleDallen Medical, Inc.20142—
+3K133844Speed TriadBiomedical Ent., Inc.20140—
+3K133780Speed XLBiomedical Ent., Inc.201415—
+3K133523Stapix Superelastic Implant Bone StaplesInstratek, Inc.20143—
+3K132875Compressyn StapleDallen Medical, Inc.20133—
+3K124045Fuseforce Implant SystemSolana Surgical, LLC201329—
+3K122113Memory Metal Staples, EasyclipStryker Corp.2013131
+3K112837Vilex EZ-Staple (Memory Bone Fixation Staple)Vilex, Inc.20125—
+3K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K070688Nexfix Compression StapleNexa Orthopedics, Inc.20070—
+3K061594Large Uni-Clip StapleNew Deal, S.A.2006103—
+4K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+4K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+4K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+4K232905Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP20230—
+4K231493NITINEX Memory Compression StapleVilex, LLC20230—
+4K220812DynaClip® Bone StapleMedShape, Inc.20222—
+4K210582EasyClip® and EasyClip® XpressStryker GmbH20221—
+4K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+4K203832FuseForce™ Flex Dynamic Compression SystemWright Medical202181
+4K210482Medline UNITE REFLEX Nitinol Staple SystemMedline Industries, Inc.20214—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+4K181781DynaClipTM Bone StapleMedShape, Inc.20182—
+4K180544DePuy Synthes Static StaplesSynthes (USA) Products, LLC20180—
+4K181410MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC20186—
+4K171703PUMA SystemPanther Orthopedics, Inc.20180—
+4K172205ExoToe StapleExotoe, LLC20180—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172405Sniper Staple System, Non-SterileTrilliant Surgical20171—
+4K170688PIT’Stop® implantIn2bones Sas20171—
+4K171473Compressyn™ StapleDallen Medical, Inc.20170—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K163226EPIC Extremely Small StapleEpic Extremely, LLC20171—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K162321EasyClip XpressRestore Surgical, LLC Dba Instratek20172—
+4K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC201622
+4K150211EzFuze Implant SystemVilex IN Tennessee, Inc.20150—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K150125Elite Nitinol Fixation SystemBiomedical Enterprises, Inc.20155—
+4K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+4K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+4K142111Arcad Compressive Osteosynthesis Staple, Express Compressive Osteosynthesis StapleNovatsep20142—
+4K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140—
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K070447Newdeal Compression PlateNewdeal Sas20071022
+5K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K250712Linkt Compression Staple SystemTrax Surgical20250—
+5K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+5K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesNovastep20230—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—