510(k) Report

Devices descending from K964226

285 later devices reach Memory Staple (20 Sizes Available) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+5K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+5K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+5K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+6K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+6K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+6K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+7K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K221395Footmotion Plating SystemNewclip Technics20220—
+7K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+7K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+7K161448Footmotion Plating SystemNewclip Technics20165—
+7K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+7K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+7K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+7K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+7K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+7K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+7K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+8K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+8K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+8K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+8K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+8K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+8K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+8K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+8K200062Foot and Ankle SystemLeith Medical, LLC20210—
+8K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+8K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+8K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+8K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+8K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+8K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+8K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+8K172886Breakaway Screw SystemParagon 2820174—
+8K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+8K171510Footmotion Plating SystemNewclip Technics20171—
+8K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+8K170843Alians Fragment SpecificNewclip Technics20171—
+8K170012Foot and Hand MotionNewclip Technics20170—
+8K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+8K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+8K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+9K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+9K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+9K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+9K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+9K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+9K211843PolyLock Plating SystemFusion Orthopedics20220—
+9K213214Xpert WristNewclip Technics20210—
+9K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+9K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+9K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+9K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+9K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+9K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+10K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+10K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+10K201149CoLink Plating SystemIn2bones USA, LLC20200—
+10K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+10K192592Axis Plating SystemExtremity Medical, LLC20190—
+10K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+11K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+11K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+11K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+11K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+12K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+12K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123