510(k) Report

Devices descending from K090926

10 later devices reach Smith & Nephew Rail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+1K200518Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd.20202—
+1K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+2K253291Excelsior SystemBlue Ocean Global20260—
+2K253202Hoffmann LRF SystemStryker GmbH20250—
+2K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+2K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+2K241357XT3 SystemBiodynamik, Inc.20251—
+2K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+3K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—