510(k) Report

Devices descending from K031428

19 later devices reach Synthes (Usa) Large External Fixation Clamps-MR Safe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172438ARBOR External Fixation SystemGlobus Medical, Inc.20180—
+1K171211OIC External Fixation SystemOrthopaedic Implant Company20170—
+1K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes201332
+1K113383Xtrafix External Fixation SystemExtraortho, Inc.20128—
+1K091258Extrafix External Fixation SystemQfx Technologies, Inc.200911—
+1K051957Reprocessed External Fixation DeviceSterilemed, Inc.200501
+2K181528Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC20192—
+2K171911Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc.20170—
+2K152755FastFrame External Fixation System-Ankle SpanningZimmer, Inc.20150—
+2K151992FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System -…Zimmer, Inc.20150—
+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—
+2K131413Xtrafix Small External Fixation SystemZimmer, Inc.20142—
+2K111155Xtrafix External Fixation SystemExtraortho, Inc.20119—
+2K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+3K232897Arthrex Small External Fixation SystemArthrex, Inc.20230—
+3K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.20221—
+3K152484FastFrame External Fixation System - Distal RadiusZimmer, Inc.20150—
+4K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.20220—