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
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+5K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K241539Activmotion SNewclip Technics20240—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K230546SignexOsteonic Co., Ltd.20242—
+5K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+5K230938ARIX Humerus SystemJeil Medical Corporation20230—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+5K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+5K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+5K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+5K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+5K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+5K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+5K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+5K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+5K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+5K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+5K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200226RetroFixRetrofix Screws, LLC20200—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+5K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+5K173135VariAx 2 SystemStryker GmbH201713—
+5K162171S4 Screw System™Subchondral Solutions20173—
+5K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+5K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+5K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+5K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+5K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+5K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+5K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+5K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+5K142581APTUS Foot SystemMedartis AG201522—
+5K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+5K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+5K143139Arthrex Fracture SystemArthrex, Inc.20151—
+5K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+5K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+5K140376Variax 2 SystemStryker Trauma AG201423—
+5K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+5K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+5K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+5K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+5K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+5K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+5K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+5K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761