510(k) Report

Devices descending from K011136

8 later devices reach Apex Fixation Pins through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110965Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC20112—
+1K080408External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External Fixaton Clamp…Advanced Orthopaedic Solutions, Inc.20082—
+1K061599Pin ScrewBk Meditech, Co., Ltd.20060—
+1K031154Sintea Biotech Schanz Screw, Model TFX.SS.XX.XSintea Biotech, Inc.20030—
+2K213905ONX Large External Fixation SystemOrthonovis, Inc.20220—
+2K171211OIC External Fixation SystemOrthopaedic Implant Company20170—
+2K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc.20141—
+3K232897Arthrex Small External Fixation SystemArthrex, Inc.20230—