510(k) Report

Devices descending from K142292

13 later devices reach Speed, Speed Shift, Speed Titan, Speed Arc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232990A’TOMIC™ Nitinol Fixation SystemRmr Ortho, LLC20240—
+1K231458Extremity StapleRestor3D20230—
+1K221947Tyber Medical Staple Fixation System (various)Tyber Medical, LLC20220—
+1K203180Arthrex DynaNite Nitinol StaplesArthrex, Inc.20201—
+1K193305DynaClip Bone StapleMedShape, Inc.20203—
+1K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC20190—
+1K181815DynaBridgeFusion Orthopedics, LLC20180—
+1K173775Clench Compression StapleF & A Foundation, LLC D.B.A. Reign Medical20180—
+1K151615TiTHON Staple with OsseoTi TechnologyBiomet Manufacturing Corp20150—
+2K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+2K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+2K220812DynaClip® Bone StapleMedShape, Inc.20222—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—