510(k) Report

Devices descending from K040701

6 later devices reach Synthes (Usa) Hydroxyapatite (HA) Coated Schanz Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250315Ronavis – FX (FX-001)AIRS, Inc.20250—
+1K160603SMV Scientific Schanz ScrewsSmv Scientific20160—
+1K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes201332
+2K171911Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc.20170—
+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—