510(k) Report

Devices descending from K970713

18 later devices reach Compass Universal Hinge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+1K132731Digifix External Fixation SystemVirak Orthopedic Research, LLC20141—
+1K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+1K094043LigamentotaxorArex USA20103—
+1K072432F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non SterileHand Biomechanics Lab, Inc.20081—
+1K012634Reprocessed External Fixation DeviceAlliance Medical, Inc.20021—
+1K992970Digit WidgetHand Biomechanics Lab, Inc.19991—
+1K980370Biosymmetric Proximal Interphalangeal Joint FixatorBiomet, Inc.19986—
+2K253291Excelsior SystemBlue Ocean Global20260—
+2K253202Hoffmann LRF SystemStryker GmbH20250—
+2K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+2K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+2K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+2K192465DigiFix Sterile KitVirak Orthopedics, LLC20190—
+2K181192PIP FixHand Biomechanics Lab, Inc.20180—
+2K122415X-Fix Dynamic External DistractorArex USA, LLC20130—
+2K051554Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp.20050—
+2K020311Clearview Wrist FixatorRigid FX Orthopedics, Incorporated20020—