510(k) Report

Devices descending from K983942

198 later devices reach Intramedullary Nail System, Locking Screw, Nail Cap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K160995NEOVIEW Plating SystemIn2bones Sas201624
+3K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+3K150867Affixus Tibial Nailing SystemBiomet, Inc.20153—
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+3K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K133376Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and RightTornier, Inc.20133—
+3K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+3K113695Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc.201232
+3K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa)2011181
+3K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc.201173
+3K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa)2011172
+3K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+3K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20091—
+3K070444Aos Tibial NailAdvanced Orthopaedic Solutions, Inc.20074—
+4K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+4K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+4K252016Arthrex Humeral NailsArthrex, Inc.20260—
+4K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+4K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K250628DynaNail TTC Fusion SystemMedShape, Inc.20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K230352Tornier Humeral Nail and Tornier Long Humeral NailTornier, Inc.20231—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K230512Gamma4 SystemStryker GmbH20230—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K222309Gamma4 SystemStryker GmbH20220—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+4K203381Dynanail Mini HybridMedShape, Inc.202141
+4K200127TELEGRAPH® EVOLUTION Humeral Nailing SystemFH Industrie20200—
+4K200430Precice® Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20203—
+4K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+4K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+4K141447Precice Trauma Nail SystemEllipse Technologies, Inc.20142—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+4K131365T2 Tibial Nailing SystemStryker Trauma AG2013174
+4K13062512MM and 13MM Tibial NailsAdvanced Orthopaedic Solutions, Inc.20133—
+4K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC201215—
+4K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+5K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20231—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+5K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+5K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K142599PRECISE Trauma Nail SystemEllipse Technologies, Incorporated20151—
+5K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A20141—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K173746Activmotion RangeNewclip Technics20181—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated20150—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K241539Activmotion SNewclip Technics20240—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+8K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+9K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—