510(k) Report

Devices descending from K013430

48 later devices reach Ace Bio Win Tibial Nailing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032097Depuy Ace Versanail Tibial NailDePuy Orthopaedics, Inc.200347—
+2K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180—
+2K150867Affixus Tibial Nailing SystemBiomet, Inc.20153—
+2K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+2K082770Zimmer Natural Nail System Tibial NailZimmer, Inc.20083515
+2K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH200811—
+2K070444Aos Tibial NailAdvanced Orthopaedic Solutions, Inc.20074—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+3K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+3K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+3K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+3K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+3K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+3K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+3K130595Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc.201323
+3K13062512MM and 13MM Tibial NailsAdvanced Orthopaedic Solutions, Inc.20133—
+3K090596Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…Zimmer, Inc.2009316
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+4K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+4K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+4K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+4K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+4K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+4K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+5K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+5K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+5K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+5K200869Gamma3 SystemStryker Trauma GmbH20209—
+5K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+5K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+6K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+6K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+6K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+6K230512Gamma4 SystemStryker GmbH20230—
+6K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+6K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+6K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+6K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+7K222309Gamma4 SystemStryker GmbH20220—
+8K261481Pangea Femur Reconstruction SystemStryker GmbH20260—