510(k) Report

Devices descending from K061493

12 later devices reach Apex Pins through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+1K253202Hoffmann LRF SystemStryker GmbH20250—
+1K250315Ronavis – FX (FX-001)AIRS, Inc.20250—
+1K211112OIC External Fixation SystemOrthopaedic Implant Company20211—
+1K172438ARBOR External Fixation SystemGlobus Medical, Inc.20180—
+1K171211OIC External Fixation SystemOrthopaedic Implant Company20170—
+1K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+2K242452Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc.20240—
+2K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+2K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+3K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—