510(k) Report

Devices descending from K972183

49 later devices reach Depuy Ace a.I.M. Titanium Tibial Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013430Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc.200148—
+2K032097Depuy Ace Versanail Tibial NailDePuy Orthopaedics, Inc.200347—
+3K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180—
+3K150867Affixus Tibial Nailing SystemBiomet, Inc.20153—
+3K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+3K082770Zimmer Natural Nail System Tibial NailZimmer, Inc.20083515
+3K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH200811—
+3K070444Aos Tibial NailAdvanced Orthopaedic Solutions, Inc.20074—
+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
+4K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+4K170972Apex Tibial Nailing SystemOrthoxel20171—
+4K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+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—
+4K090596Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…Zimmer, Inc.2009316
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+5K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+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—
+5K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+5K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+6K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+6K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+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—
+6K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+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—
+7K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+7K230512Gamma4 SystemStryker GmbH20230—
+7K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+7K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+7K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+7K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+8K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+8K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+8K222309Gamma4 SystemStryker GmbH20220—
+9K261481Pangea Femur Reconstruction SystemStryker GmbH20260—