510(k) Report

Devices descending from K111678

58 later devices reach Ortho Solutions Extremity Fixation Implants for Osteosysnthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+1K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+1K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+1K151407RECON systemNormed Medizin-Technik GmbH20154—
+1K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+1K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+1K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+2K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+2K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+2K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+2K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+2K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+2K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K143365Eminent Foot Plate SystemEminent Spine20151—
+2K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—