510(k) Report

Devices descending from K964532

394 later devices reach Multitak SS Suture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+7K132502Variax 2 SystemStryker Trauma AG201321—
+7K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+8K254280F.A.S.T ScrewSteps Ortho20260—
+8K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+8K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+8K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+8K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+8K254215Arthrex Beaming SystemArthrex, Inc.20261—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+8K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+8K253538TeKBrace Knotless AnchorTheramicro20260—
+8K253695LigaMendRiverpoint Medical, LLC20260—
+8K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+8K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+8K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+8K243988RootMend MRRRiverpoint Medical, LLC20250—
+8K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+8K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+8K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+8K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+8K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+8K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+8K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+8K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+8K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+8K233659Suture WingOsteonic Co., Ltd.20230—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+8K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+8K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+8K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+8K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+8K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+8K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+8K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+8K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+8K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+8K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+8K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+8K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+8K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+8K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+8K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+8K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+8K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+8K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+8K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+8K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+8K173556Injection ScrewBiedermann Medtech, Inc.20180—
+8K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+8K172921Stryker Self-Punching ICONIXStryker20170—
+8K171060OrthoButton ALRiverpoint Medical20178—
+8K140769Variax 2 SystemStryker Trauma AG201419—
+9K262975Arthrex Beaming SystemArthrex, Inc.20260—
+9K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+9K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+9K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+9K241912BiochargeNanofiber Solutions, LLC20240—
+9K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+9K240194ProCinch, QuadCinchRiverpoint Medical20240—
+9K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+9K233552IDEAL ZiploopRiverpoint Medical20230—
+9K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+9K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+9K230212OrthoButton ALRiverpoint Medical, LLC20232—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+9K202399OrthoButton FLRiverpoint Medical20201—
+9K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+9K173135VariAx 2 SystemStryker GmbH201713—
+9K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+10K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+10K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+10K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+10K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+10K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+10K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+10K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+10K180500VariAx 2 SystemStryker GmbH201812—
+11K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+11K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+11K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+11K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+11K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+11K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+12K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+12K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+12K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+13K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+13K233919VariAx 2 Distal Radius SystemStryker GmbH20242—