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
+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
+7K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+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—
+8K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+8K181262SpineJack Expansion KitVexim SA20184—
+8K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+9K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+9K240084V-STRUT® Vertebral ImplantHyprevention20240—
+9K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+9K202393SpineJack Expansion KitStryker Corporation20203—
+10K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+11K223294SpineJack® Expansion KitStryker Instruments20221—
+12K250637VCFix Spinal SystemAmber Implants20250—