510(k) Report

Devices descending from K961497

628 later devices reach Profyle Titanium Hand and Small Fragment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+5K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+5K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+6K262975Arthrex Beaming SystemArthrex, Inc.20260—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+6K261511Xpert AnkleNewclip Technics20260—
+6K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+6K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+6K254182AsterOsteonic Co., Ltd.20260—
+6K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K242988Genostis Osteosynthesis SystemGenostis AF20250—
+6K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+6K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+6K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+6K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+6K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+6K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+6K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+6K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+6K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+6K221395Footmotion Plating SystemNewclip Technics20220—
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K211435PAO Cortical ScrewMedacta International S.A.20210—
+6K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K210159IntraLock SystemFusion Orthopedics, LLC20210—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+6K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+6K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K202307Activ FuseNewclip Technics20200—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+6K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+6K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+6K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+6K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+6K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+6K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+6K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+6K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+6K191636APTUS Foot SystemMedartis AG20190—
+6K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+6K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+6K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+6K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+6K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+6K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+6K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+6K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+6K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+6K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+6K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+6K161448Footmotion Plating SystemNewclip Technics20165—
+6K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+6K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+6K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+6K153379AxSOS 3TiStryker GmbH201625—
+6K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+6K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+6K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+6K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+6K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+6K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+6K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+6K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+6K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+6K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+6K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+6K141905Pro-Link Wedge SystemLife Spine201411—