510(k) Report

Devices descending from K970290

28 later devices reach Ebi X Fix Dynafix Mini External Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140158S.E.a.L. Fracture Fusion TubeDne, LLC20140—
+1K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma200821
+1K052196Vilex X-FixVilex, Inc.200513—
+1K052005R&R External Fixation SystemR&R Medical, Inc.200511—
+1K012645Reprocessed Ebi External Fixation DevicesAlliance Medical Corp.20021—
+2K202143Dynex MicroVilex, LLC20201—
+2K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+2K180832SALVATION External Fixation SystemWrightmedicaltechnologyinc20181—
+2K162033SALVATION External Fixation SystemWright Medical20173—
+2K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+2K153635SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc20164—
+2K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V20130—
+2K113106Dne External Fixation SystemDne, LLC20122—
+2K102843Mac Male AdapterBiomet Trauma (Aka Ebi, LLC)20110—
+2K100137Sidekick Circular Fixator System: Struts and HingesWrightmedicaltechnologyinc20106—
+2K100857Fusion Medical Ring Lock SystemJohn J Riccio20101—
+2K052064Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp.20050—
+3K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+3K252555Medusa Orthopedics Boa External Fixation SystemMedusa Orthopedics, LLC20250—
+3K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+3K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+3K212552Correx SoftwareVilex, LLC20210—
+3K200343FusionFrame Ring Lock SystemGlw Medical Innovation20200—
+3K173883External Fixation SystemLife Spine, Inc.20180—
+3K151580D.N.E. External Fixation SystemDne, LLC201601
+3K152045SALVATION® External Fixation SystemWrightmedicaltechnologyinc20150—
+4K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—