510(k) Report

Devices descending from K083447

92 later devices reach Memometal Anchorage Bone Plate System, Models PLSS/PLSL… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+1K172148Anchorage Bone Plating SystemStryker GmbH20184—
+1K163293Colink™ Plating SystemIn2bones USA, LLC2017212
+1K161448Footmotion Plating SystemNewclip Technics20165—
+1K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+1K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+1K151277Airlock® osteosynthesis plate systemNovastep20152—
+1K143523Airlock osteosynthesis plate systemNovastep20154—
+1K132594Crosscheck Plating SystemSolana Surgical, LLC20132321
+1K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+2K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+2K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+2K221395Footmotion Plating SystemNewclip Technics20220—
+2K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+2K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+2K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+2K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+2K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+2K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+2K201149CoLink Plating SystemIn2bones USA, LLC20200—
+2K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+2K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+2K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+2K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+2K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+2K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+2K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+2K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+2K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K171510Footmotion Plating SystemNewclip Technics20171—
+2K170843Alians Fragment SpecificNewclip Technics20171—
+2K170012Foot and Hand MotionNewclip Technics20170—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K143365Eminent Foot Plate SystemEminent Spine20151—
+2K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+3K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K211843PolyLock Plating SystemFusion Orthopedics20220—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K213214Xpert WristNewclip Technics20210—
+3K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+3K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+4K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—