510(k) Report

Devices descending from K981529

211 later devices reach Titanium Intramedullary Nail, Titanium Locking Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K090596Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…Zimmer, Inc.2009316
+3K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+3K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc.20093916
+3K042440Alphatec Femoral Trochanteric Nail (FTN) SystemAlphatec/Nexmed20040—
+4K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+4K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.20260—
+4K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+4K252016Arthrex Humeral NailsArthrex, Inc.20260—
+4K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+4K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+4K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+4K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+4K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+4K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K230352Tornier Humeral Nail and Tornier Long Humeral NailTornier, Inc.20231—
+4K230512Gamma4 SystemStryker GmbH20230—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K222309Gamma4 SystemStryker GmbH20220—
+4K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp.20222—
+4K221115Flow-NailFlow-Fx, LLC20221—
+4K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+4K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K200127TELEGRAPH® EVOLUTION Humeral Nailing SystemFH Industrie20200—
+4K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+4K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+4K190321Pediatric Nailing PlatformFemurOrthoPediatrics Corp.20190—
+4K191598AOS ES Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc.20190—
+4K191238Zimmer Guide Wire DevicesZimmer, Inc.20190—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K183162Affixus Hip Fracture NailBiomet, Inc.20182—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K172114Zimmer Natural Nail SystemZimmer, Inc.201711—
+4K163589SIGN IM NailSign Fracture Care International20170—
+4K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K142599PRECISE Trauma Nail SystemEllipse Technologies, Incorporated20151—
+4K142281Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc.2014107
+4K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A20141—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K130595Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc.201323
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC201215—
+4K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH2009165
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+5K234075Flow-NailFlow-Fx, LLC20240—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH20234—
+5K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K210285Adaptable Ortho Innovations Intramedullary Nail SystemAdaptable Ortho Innovations, LLC20210—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+5K192312Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH20194—
+5K181827Affixus Natural Nail System Humeral NailZimmer GmbH20186—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+5K181375Apex Femoral Nailing SystemOrthoxel20180—
+5K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated20150—
+5K143321ITST Intertrochanteric/Subtrochanteric Fixation SystemZimmer, Inc.201502
+5K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH201210—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH20201—