510(k) Report

Devices descending from K001354

28 later devices reach Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170923JAWS (TM) Nitinol Staple SystemParagon 28201731
+1K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc.2014133
+1K122871Compressyn StapleDallen Medical, Inc.20134—
+1K071477Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC20071—
+1K023488Osstaple, CraniofacialBiomedical Enterprises, Inc.20020—
+1K023486Osstaple, MaxillofacialBiomedical Enterprises, Inc.20020—
+1K023203OsstapleBiomedical Ent., Inc.20020—
+2K232990A’TOMIC™ Nitinol Fixation SystemRmr Ortho, LLC20240—
+2K231458Extremity StapleRestor3D20230—
+2K223056JAWS Nitinol Staple SystemParagon 28, Inc.20232—
+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—
+2K141550Instafix Shape Memory Fixation SystemOt Medical20140—
+2K140358Compressyn StapleDallen Medical, Inc.20142—
+2K132875Compressyn StapleDallen Medical, Inc.20133—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+3K230550JAWS Nitinol Staple SystemParagon 28, Inc.20231—
+3K220812DynaClip® Bone StapleMedShape, Inc.20222—
+3K172205ExoToe StapleExotoe, LLC20180—
+3K171473Compressyn™ StapleDallen Medical, Inc.20170—
+4K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+4K261121Megalodon Dynamic Compression SystemParagon 28, Inc.20260—