510(k) Report

Devices descending from K131722

24 later devices reach I.T.S. Extremity Fixation Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+1K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+1K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+1K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+1K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+1K143365Eminent Foot Plate SystemEminent Spine20151—
+1K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+2K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+2K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+2K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+2K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+2K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+2K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+2K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+2K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+3K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+3K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+3K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+4K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—