510(k) Report

Devices descending from K070561

68 later devices reach Kmedic Internal/External Fixation Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100736Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH201065—
+1K082833NBX - Non-Bridging External Fixator - ShoulderNutek Orthopaedics, Inc.20090—
+1K082017Starr Frame Steinmann PinStarr Frame, LLC20080—
+2K231339Tyber Medical Pin and Wire System (various)Tyber Medical, LLC20230—
+2K213982Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide WiresPacific Instruments20220—
+2K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited20220—
+2K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+2K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.20183—
+2K142134C-Wire Double Ended Orthopedic WiresConmed Corporation, Largo20140—
+2K131459Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG201312—
+2K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+2K120787Merete Locking Bone Plate System IiiMerete Medical GmbH201212—
+2K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG201224—
+2K110047Verticor K-Wire SystemVerticor, Ltd.20110—
+2K102072Memometal Implants (K-Snap & TI-Fuse)Memometal Technologies20101—
+3K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+3K241695Extremity All Suture SystemField Orthopaedics20240—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts20234—
+3K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K192768Temporary Fixation PinsEisertech, LLC20191—
+3K182171SMV Scientific K-Wire and PinsSummit Medventures20181—
+3K171715HammerTube SystemParagon 28201861
+3K173693Orbitum Bone Staple Implant, X and VIOrthovestments, LLC20180—
+3K172205ExoToe StapleExotoe, LLC20180—
+3K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+3K151160Arcus Staple SystemNextremity Solutions, Inc.20151—
+3K143049LYNC intramedullary implantNovastep20150—
+3K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K130627Swing-Off ScrewAdvanced Interventional Technology, LLC20130—
+4K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.20260—
+4K250315Ronavis – FX (FX-001)AIRS, Inc.20250—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K231905Electro-Spec Steri-CapsElectro-Spec, Inc.20230—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+4K210456Ligament StapleMedacta International S.A.20210—
+4K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+4K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+4K183228HammerToe Compression SystemParagon 28, Inc.20190—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—