510(k) Report

Devices descending from K914453

118 later devices reach Universal Tibial Nail and Unreamed Tibial Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical, Ltd.20240—
+1K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+1K133166Ins Hilden Tibial ArzztTruemed Group, LLC20141—
+1K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+1K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+1K092771Dyna Locking IM NailU&I Corp.20090—
+1K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH200811—
+1K051965Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH20063—
+1K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd.200332—
+1K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd.200154—
+1K013430Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc.200148—
+1K990717Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd.199956—
+1K961027Orthofix Tibial Nailing SystemOrthofix, Inc.19961—
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+2K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180—
+2K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+2K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+2K142451OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH20151—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+2K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+2K101939Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH201001
+2K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+2K071679Metafix and Fixion FA Intramedullary Nailing SystemsDisc-O-Tech Medical Technologies, Ltd.20070—
+2K032097Depuy Ace Versanail Tibial NailDePuy Orthopaedics, Inc.200347—
+2K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd.200332—
+2K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…Disco-O-Tech Medical Technologies, Ltd.200253—
+2K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd.2002541
+2K973944Orthofix Femoral Nailing SytemOrthofix Srl19970—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K181026OsteoBridge™ IDSF SystemMerete GmbH201803
+3K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K163589SIGN IM NailSign Fracture Care International20170—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K150867Affixus Tibial Nailing SystemBiomet, Inc.20153—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K131636Polarus ConnectAcumed, LLC20130—
+3K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+3K082770Zimmer Natural Nail System Tibial NailZimmer, Inc.20083515
+3K070444Aos Tibial NailAdvanced Orthopaedic Solutions, Inc.20074—
+3K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd.20040—
+3K032358B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd.200316—
+4K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+4K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+4K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+4K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+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—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+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—
+4K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+4K130595Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc.201323
+4K13062512MM and 13MM Tibial NailsAdvanced Orthopaedic Solutions, Inc.20133—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K090596Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…Zimmer, Inc.2009316
+4K040612Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd.200413—
+4K034037Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd.200415—
+5K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+5K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+5K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+5K053336Staxx FX SystemSpine Wave, Inc.200612—
+5K040939Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd.20040—
+6K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+6K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+6K200869Gamma3 SystemStryker Trauma GmbH20209—
+6K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+6K080108Cortoss Bone Augmentation MaterialOrthovita, Inc.200904
+6K063606Modification to Staxx FX SystemSpine Wave, Inc.200711—
+7K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+7K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K242247ARIX Femur Nail SystemJeil Medical Corporation20251—