510(k) Report

Devices descending from K063049

468 later devices reach Synthes (Usa) Modular Mini Fragment LCP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+4K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+4K254182AsterOsteonic Co., Ltd.20260—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+4K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+4K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+4K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+4K230938ARIX Humerus SystemJeil Medical Corporation20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+4K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+4K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+4K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+4K202307Activ FuseNewclip Technics20200—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+4K191867ATLAS Plating SystemMiRus, LLC20200—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+4K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+4K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+4K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+4K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+4K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+4K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+4K190830TDM Screw SystemsTdm Co., Ltd.20191—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K173641Activ AnkleNewclip Technics20183—
+4K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+4K172350AxSOS 3 TiStryker GmbH201717—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+4K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+4K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K151769Anchorage 2 CP SystemStryker GmbH20150—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+4K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+5K254280F.A.S.T ScrewSteps Ortho20260—
+5K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+5K262344Large Compression ScrewsTriMed, Inc.20260—