510(k) Report

Devices descending from K100736

65 later devices reach Kirschner and Guide Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231339Tyber Medical Pin and Wire System (various)Tyber Medical, LLC20230—
+1K213982Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide WiresPacific Instruments20220—
+1K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited20220—
+1K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+1K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.20183—
+1K142134C-Wire Double Ended Orthopedic WiresConmed Corporation, Largo20140—
+1K131459Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG201312—
+1K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+1K120787Merete Locking Bone Plate System IiiMerete Medical GmbH201212—
+1K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG201224—
+1K110047Verticor K-Wire SystemVerticor, Ltd.20110—
+1K102072Memometal Implants (K-Snap & TI-Fuse)Memometal Technologies20101—
+2K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+2K241695Extremity All Suture SystemField Orthopaedics20240—
+2K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+2K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts20234—
+2K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K192768Temporary Fixation PinsEisertech, LLC20191—
+2K182171SMV Scientific K-Wire and PinsSummit Medventures20181—
+2K171715HammerTube SystemParagon 28201861
+2K173693Orbitum Bone Staple Implant, X and VIOrthovestments, LLC20180—
+2K172205ExoToe StapleExotoe, LLC20180—
+2K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+2K151160Arcus Staple SystemNextremity Solutions, Inc.20151—
+2K143049LYNC intramedullary implantNovastep20150—
+2K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+2K131061Restore Bunion Correction SystemNextremity Solutions201315—
+2K130627Swing-Off ScrewAdvanced Interventional Technology, LLC20130—
+3K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.20260—
+3K250315Ronavis – FX (FX-001)AIRS, Inc.20250—
+3K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+3K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K231905Electro-Spec Steri-CapsElectro-Spec, Inc.20230—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+3K210456Ligament StapleMedacta International S.A.20210—
+3K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+3K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+3K183228HammerToe Compression SystemParagon 28, Inc.20190—
+3K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—