510(k) Report

Devices descending from K124022

20 later devices reach Speed Shift through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181866MotoCLIP/HiMAX Step Staple Implant SystemCrossroads Extremity Systems, LLC20180—
+1K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+1K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc.2014133
+1K133844Speed TriadBiomedical Ent., Inc.20140—
+1K133780Speed XLBiomedical Ent., Inc.201415—
+2K232990A’TOMIC™ Nitinol Fixation SystemRmr Ortho, LLC20240—
+2K231458Extremity StapleRestor3D20230—
+2K221947Tyber Medical Staple Fixation System (various)Tyber Medical, LLC20220—
+2K203180Arthrex DynaNite Nitinol StaplesArthrex, Inc.20201—
+2K193305DynaClip Bone StapleMedShape, Inc.20203—
+2K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC20190—
+2K181815DynaBridgeFusion Orthopedics, LLC20180—
+2K173775Clench Compression StapleF & A Foundation, LLC D.B.A. Reign Medical20180—
+2K151615TiTHON Staple with OsseoTi TechnologyBiomet Manufacturing Corp20150—
+2K150125Elite Nitinol Fixation SystemBiomedical Enterprises, Inc.20155—
+2K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+3K220812DynaClip® Bone StapleMedShape, Inc.20222—
+4K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—