510(k) Report

Devices descending from K201253

5 later devices reach Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253291Excelsior SystemBlue Ocean Global20260—
+1K253202Hoffmann LRF SystemStryker GmbH20250—
+1K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+1K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+1K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—