510(k) Report

Devices descending from K053472

31 later devices reach Hoffmann II Mri External Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+1K122284Hoffmann 3Stryker Corp.20126—
+1K111786Hoffmann 3 Modular External Fixation SystemStryker Corp.201213—
+1K111155Xtrafix External Fixation SystemExtraortho, Inc.20119—
+1K091258Extrafix External Fixation SystemQfx Technologies, Inc.200911—
+1K080408External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External Fixaton Clamp…Advanced Orthopaedic Solutions, Inc.20082—
+2K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+2K230067Para-Fix External Fixation SystemNew Paradigm Biomedical20230—
+2K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd.20190—
+2K173883External Fixation SystemLife Spine, Inc.20180—
+2K172438ARBOR External Fixation SystemGlobus Medical, Inc.20180—
+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—
+2K113770Orthofix Galaxy Fixation SystemOrthofix Srl2012613
+2K121252Hoffmann 3 Modular External Fixation SystemStryker Corp.20121—
+2K113383Xtrafix External Fixation SystemExtraortho, Inc.20128—
+2K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+3K242452Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc.20240—
+3K232897Arthrex Small External Fixation SystemArthrex, Inc.20230—
+3K200491Bfix Orthopedic External Fixator SystemsAike (Shanghai) Medical Instrument Co., Ltd.20210—
+3K181528Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC20192—
+3K153233Galaxy UNYCO SystemOrthofix Srl201611
+3K152755FastFrame External Fixation System-Ankle SpanningZimmer, Inc.20150—
+3K151992FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System -…Zimmer, Inc.20150—
+3K141760Orthofix Galaxy WristOrthofix Srl201401
+3K141697Xtrafix External Fixation System, Xtrafix Small External Fixation SystemZimmer, Inc.20141—
+3K131413Xtrafix Small External Fixation SystemZimmer, Inc.20142—
+4K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.20221—
+4K170146Galaxy UNYCO SystemOrthofix Srl20170—
+4K152484FastFrame External Fixation System - Distal RadiusZimmer, Inc.20150—
+5K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.20220—