510(k) Report

Devices descending from K133780

15 later devices reach Speed XL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150125Elite Nitinol Fixation SystemBiomedical Enterprises, Inc.20155—
+1K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc.2014133
+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—
+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—