510(k) Report

Devices descending from K980370

6 later devices reach Biosymmetric Proximal Interphalangeal Joint Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132731Digifix External Fixation SystemVirak Orthopedic Research, LLC20141—
+1K094043LigamentotaxorArex USA20103—
+1K992970Digit WidgetHand Biomechanics Lab, Inc.19991—
+2K192465DigiFix Sterile KitVirak Orthopedics, LLC20190—
+2K122415X-Fix Dynamic External DistractorArex USA, LLC20130—
+2K020311Clearview Wrist FixatorRigid FX Orthopedics, Incorporated20020—