510(k) Report

Devices descending from K950595

110 later devices reach Luhr Mandibular/Small Fixation Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011946The Spin Snap-Off ScrewNew Deal, S.A.20016—
+1K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc.199711—
+1K972154Cohen DistractorHowmedica Leibinger, Inc.19978—
+1K962233Twist-Off ScrewLandos, Inc.199692—
+2K253108VEOFIX Snap Off ScrewSteps Ortho20260—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie20170—
+2K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp2014362
+2K121235Leibinger Advance Internal Midface Distraction SystemStryker20140—
+2K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial20103—
+2K070039Memometal Fixos ScrewsMemometal Technologies200784—
+2K051323Merete Twistcut Snap-Off Bone ScrewMerete Medical GmbH20052—
+2K031708Osteomed Maxillary/Lefort Iii Distraction SystemOsteomed LP20030—
+2K013618Intraoral Mandibular Distraction SystemOsteomed Corp.20026—
+2K013672Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC20020—
+2K990944Osteomed Intraoral Distraction SystemOsteomed Corp.19997—
+2K982604Lorenz Maxilla (LE Fort) Distraction SystemWalter Lorenz Surgical, Inc.19981—
+2K973484Chin DistractorHowmedica, Inc.19971—
+3K211628MIS Precision Chevron Bunion SystemRelja Innovations, LLC20221—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K190035Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc.20194—
+3K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+3K170012Foot and Hand MotionNewclip Technics20170—
+3K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+3K143146Nexis osteosynthesis snap-off screwsNovastep20152—
+3K143229Nexis osteosynthesis compressive screwsNovastep20153—
+3K133398Stryker Pediatric Mandible DistractorStryker20141—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K121502Synthes Curvilinear Distraction SystemSynthes, Inc.20121—
+3K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+3K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP20055—
+3K030790Osteomed Alveolar Distraction SystemOsteomed LP20030—
+4K262075Lapidus Screw KitRelja Innovations, LLC20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+4K223468Nexis® compressive screwsNovastep20230—
+4K230397Cut Screw - Percutaneous Compression ScrewGM Dos Reis Industria e Comercio Ltda.20230—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K220921Metal Bone ScrewDouble Medical Technology, Inc.20221—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+4K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+4K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+4K181504Stryker Pediatric Mandibular Distractor 2Stryker20180—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+4K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP20062—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+5K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+5K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+5K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+5K190830TDM Screw SystemsTdm Co., Ltd.20191—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K162171S4 Screw System™Subchondral Solutions20173—
+5K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K231860TDM Screw SystemTdm Co., Ltd.20240—
+6K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+6K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—