510(k) Report

Devices descending from K022325

521 later devices reach Normed Titanium Osteotomy Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K261191Alians Elbow SNewclip Technics20260—
+5K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K254215Arthrex Beaming SystemArthrex, Inc.20261—
+5K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+5K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+5K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+5K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+5K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+5K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+5K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+5K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+5K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+5K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+5K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+5K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+5K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K230546SignexOsteonic Co., Ltd.20242—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+5K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+5K230204ALPHALOK Plating SystemVilex, LLC20230—
+5K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+5K221558ALPHALOK Plating SystemVilex, LLC20222—
+5K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+5K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+5K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+5K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+5K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+5K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+5K211843PolyLock Plating SystemFusion Orthopedics20220—
+5K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+5K213214Xpert WristNewclip Technics20210—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+5K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+5K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+5K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+5K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+5K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+5K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+5K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K200226RetroFixRetrofix Screws, LLC20200—
+5K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+5K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+5K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+5K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+5K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+5K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+5K190830TDM Screw SystemsTdm Co., Ltd.20191—
+5K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+5K173641Activ AnkleNewclip Technics20183—