510(k) Report

Devices descending from K040022

202 later devices reach Stryker Leibinger Universal Distal Radius System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+1K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+1K133974Variax Distal Radius Plating SystemStryker Leibinger GmbH201420—
+1K133246Zimmer Distal Radius Plating SystemZimmer, Inc.20132—
+1K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+1K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+1K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics201156—
+1K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp.201080—
+1K073527Variax Elbow SystemHowmedica Osteonics Corp.200861—
+1K062498Profyle SystemHowmedica Osteonics Corp.2006811
+1K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.20051571
+1K042766Orthofix Volar Distal Radial PlateOrthofix, Inc.20041—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K253906Xpert HandNewclip Technics20260—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+2K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+2K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+2K232144Sterile Products of the APTUS SystemMedartis AG20233—
+2K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+2K213214Xpert WristNewclip Technics20210—
+2K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K191972ARIX Wrist SystemJeil Medical Corporation20190—
+2K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+2K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+2K181009APTUS CMC-I Fusion Plate SystemMedartis AG20180—
+2K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.20183—
+2K180500VariAx 2 SystemStryker GmbH201812—
+2K171624IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH20180—
+2K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+2K170843Alians Fragment SpecificNewclip Technics20171—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K161861APTUS® Coronoid 2.0Medartis AG20170—
+2K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+2K151468ARIX Wrist SystemJeil Medical Corporation20167—
+2K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+2K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+2K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+2K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+2K141232Aptus Ulna Shortening 2.5Medartis AG201451
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K132769Acumed Hand Plating SystemAcumed, LLC20147—
+2K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+2K131566Arix Hand SystemJeil Medical Corporation20138—
+2K132502Variax 2 SystemStryker Trauma AG201321—
+2K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+2K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+2K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+2K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+2K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+2K103332Aptus Ulna PlatesMedartis AG201171—
+2K102537Aptus 1.5 TrilockMedartis AG201019—
+2K101936Contours VSP Iii Volar Plating SystemOrthofix, Inc.20100—
+2K101056Variax Elbow SystemHowmedica Osteonics Corp.201058—
+2K093433Variax Elbow System Plate Line ExtensionHowmedica Osteonics Corp.20101—
+2K092671Variax Elbow System Line ExtensionHowmedica Osteonics Corp.20090—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+3K260761APTUS Clavicle System 2.8Medartis AG20260—
+3K254215Arthrex Beaming SystemArthrex, Inc.20261—
+3K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+3K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+3K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+3K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+3K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+3K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+3K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+3K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K241695Extremity All Suture SystemField Orthopaedics20240—
+3K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+3K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+3K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+3K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+3K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—