510(k) Report

Devices descending from K051306

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230067Para-Fix External Fixation SystemNew Paradigm Biomedical20230—
+1K122284Hoffmann 3Stryker Corp.20126—
+1K111786Hoffmann 3 Modular External Fixation SystemStryker Corp.201213—
+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
+2K113770Orthofix Galaxy Fixation SystemOrthofix Srl2012613
+2K121252Hoffmann 3 Modular External Fixation SystemStryker Corp.20121—
+3K242452Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc.20240—
+3K200491Bfix Orthopedic External Fixator SystemsAike (Shanghai) Medical Instrument Co., Ltd.20210—
+3K153233Galaxy UNYCO SystemOrthofix Srl201611
+3K141760Orthofix Galaxy WristOrthofix Srl201401
+4K170146Galaxy UNYCO SystemOrthofix Srl20170—