510(k) Report

Devices descending from K070031

114 later devices reach Memometal Memory Staples through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192447Superelastic StapleNeosteo20200—
+1K153770OS2(R)-VP Varisation StapleIn2bones Sas20164—
+1K153395OS2-C Compression StapleIn2bones Sas20167—
+1K142727CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems201481
+1K142148Orthohelix Staple SystemOrthohelix Surgical Designs, Inc.20140—
+1K133523Stapix Superelastic Implant Bone StaplesInstratek, Inc.20143—
+1K130832Orthohelix Staple SystemOrthohelix Surgical Designs, Inc.20131—
+1K124045Fuseforce Implant SystemSolana Surgical, LLC201329—
+1K123926Metasurg Nitinol Staple ImplantMetasurg20136—
+1K122113Memory Metal Staples, EasyclipStryker Corp.2013131
+1K112837Vilex EZ-Staple (Memory Bone Fixation Staple)Vilex, Inc.20125—
+1K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+2K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+2K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+2K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+2K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+2K231493NITINEX Memory Compression StapleVilex, LLC20230—
+2K210582EasyClip® and EasyClip® XpressStryker GmbH20221—
+2K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+2K203832FuseForce™ Flex Dynamic Compression SystemWright Medical202181
+2K210482Medline UNITE REFLEX Nitinol Staple SystemMedline Industries, Inc.20214—
+2K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+2K181781DynaClipTM Bone StapleMedShape, Inc.20182—
+2K181866MotoCLIP/HiMAX Step Staple Implant SystemCrossroads Extremity Systems, LLC20180—
+2K181410MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC20186—
+2K171703PUMA SystemPanther Orthopedics, Inc.20180—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K170688PIT’Stop® implantIn2bones Sas20171—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K162354Sniper Staple SystemTrilliant Surgical, Ltd.20175—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K162321EasyClip XpressRestore Surgical, LLC Dba Instratek20172—
+2K163440Stealth Staple SystemFirst Ray, LLC20173—
+2K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC201622
+2K150211EzFuze Implant SystemVilex IN Tennessee, Inc.20150—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+2K142111Arcad Compressive Osteosynthesis Staple, Express Compressive Osteosynthesis StapleNovatsep20142—
+2K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140—
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+3K250712Linkt Compression Staple SystemTrax Surgical20250—
+3K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+3K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesNovastep20230—
+3K232905Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP20230—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K231885Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LP20233—
+3K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+3K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+3K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC20190—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K181815DynaBridgeFusion Orthopedics, LLC20180—
+3K180544DePuy Synthes Static StaplesSynthes (USA) Products, LLC20180—
+3K172405Sniper Staple System, Non-SterileTrilliant Surgical20171—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K163226EPIC Extremely Small StapleEpic Extremely, LLC20171—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+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
+4K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+4K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+4K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts20234—
+4K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+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—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—