510(k) Report

Devices descending from K964226

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K151615TiTHON Staple with OsseoTi TechnologyBiomet Manufacturing Corp20150—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+3K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+3K142111Arcad Compressive Osteosynthesis Staple, Express Compressive Osteosynthesis StapleNovatsep20142—
+3K130019J-Screw Compression ScrewCompetitive Engineering, Inc.20140—
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+3K141550Instafix Shape Memory Fixation SystemOt Medical20140—
+3K140358Compressyn StapleDallen Medical, Inc.20142—
+3K133515Peek Fusion ImplantMtp Solutions, LLC20142—
+3K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC201431—
+3K133780Speed XLBiomedical Ent., Inc.201415—
+3K133520Hammerlock 2Biomedical Enterprises, Inc.20145—
+3K132875Compressyn StapleDallen Medical, Inc.20133—
+3K130859Hammertoe Correction SystemArthrosurface, Inc.20134—
+3K122031Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC20129—
+3K070447Newdeal Compression PlateNewdeal Sas20071022
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+4K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions20250—
+4K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+4K250712Linkt Compression Staple SystemTrax Surgical20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesNovastep20230—
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K232905Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP20230—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K231885Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LP20233—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226—
+4K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+4K220812DynaClip® Bone StapleMedShape, Inc.20222—
+4K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+4K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+4K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+4K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC20194—
+4K183228HammerToe Compression SystemParagon 28, Inc.20190—
+4K180544DePuy Synthes Static StaplesSynthes (USA) Products, LLC20180—
+4K172205ExoToe StapleExotoe, LLC20180—
+4K172405Sniper Staple System, Non-SterileTrilliant Surgical20171—
+4K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+4K163226EPIC Extremely Small StapleEpic Extremely, LLC20171—
+4K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc.20170—
+4K161303dynaMX™ Compression PlateMx Orthopedics, Corp.20171—
+4K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+4K152627IFS Fixation Scaffold SystemMetric Medical Devices, Inc.20160—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K152710HammerFiX DeviceExtremity Medical, LLC20151—
+4K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+4K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+4K142478opti-ToeGraham Medical Technologies, LLC (D.B.A.Gramedica)20151—
+4K150125Elite Nitinol Fixation SystemBiomedical Enterprises, Inc.20155—
+4K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+4K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140—
+4K140970One-Piece Peek Fusion ImplantMtp Solutions, LLC20140—
+4K093914Newdeal Compression PlatesNewdeal Sas2011985
+4K091609Newdeal Compression PlateNewdeal Sas200921
+5K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+5K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+5K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts20234—
+5K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+5K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+5K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+5K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20212—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K193345Arthrex DynaNite Compression PlateArthrex, Inc.20200—
+5K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—