510(k) Report

Devices descending from K082650

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181528Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC20192—
+1K170146Galaxy UNYCO SystemOrthofix Srl20170—
+1K153233Galaxy UNYCO SystemOrthofix Srl201611
+1K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl201421
+1K140675Emerge External Fixation SystemEmerge Medical, Inc.20141—
+1K131413Xtrafix Small External Fixation SystemZimmer, Inc.20142—
+1K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes201332
+1K113770Orthofix Galaxy Fixation SystemOrthofix Srl2012613
+1K111155Xtrafix External Fixation SystemExtraortho, Inc.20119—
+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—
+2K171911Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc.20170—
+2K152484FastFrame External Fixation System - Distal RadiusZimmer, Inc.20150—
+2K150579Cardinal Health External Fixation SystemCardinalhealth20150—
+2K141760Orthofix Galaxy WristOrthofix Srl201401
+2K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc.20141—
+2K141697Xtrafix External Fixation System, Xtrafix Small External Fixation SystemZimmer, Inc.20141—
+2K113383Xtrafix External Fixation SystemExtraortho, Inc.20128—
+3K232897Arthrex Small External Fixation SystemArthrex, Inc.20230—
+3K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.20220—
+3K152755FastFrame External Fixation System-Ankle SpanningZimmer, Inc.20150—
+3K151992FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System -…Zimmer, Inc.20150—