510(k) Report

Devices descending from K090658

15 later devices reach Synthes External Fixation Devices, MR Conditional through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181528Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC20192—
+1K171911Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc.20170—
+1K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes201332
+1K113770Orthofix Galaxy Fixation SystemOrthofix Srl2012613
+1K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+2K242452Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc.20240—
+2K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.20221—
+2K200491Bfix Orthopedic External Fixator SystemsAike (Shanghai) Medical Instrument Co., Ltd.20210—
+2K141760Orthofix Galaxy WristOrthofix Srl201401
+2K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl201421
+2K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc.20141—
+3K232897Arthrex Small External Fixation SystemArthrex, Inc.20230—
+3K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.20220—
+3K153233Galaxy UNYCO SystemOrthofix Srl201611
+4K170146Galaxy UNYCO SystemOrthofix Srl20170—