510(k) Report

Devices descending from K990194

310 later devices reach Biobutton through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+7K254215Arthrex Beaming SystemArthrex, Inc.20261—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+7K254176SinefixBAAT Medical Products B.V.20260—
+7K260405FiberTape ButtonArthrex, Inc.20260—
+7K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+7K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+7K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+7K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+7K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+7K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+7K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+7K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+7K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+7K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+7K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+7K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+7K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+7K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+7K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+7K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+7K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+7K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+7K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+7K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+7K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+7K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+7K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+7K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+7K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+7K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+7K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+7K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+7K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+7K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+7K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+7K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+7K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+7K183331Parcus GFS BTBParcus Medical, LLC20193—
+7K173556Injection ScrewBiedermann Medtech, Inc.20180—
+7K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+7K160655OrthoButton CLRiverpoint Medical20169—
+7K152711Parcus GFS NakedParcus Medical, LLC20154—
+7K140769Variax 2 SystemStryker Trauma AG201419—
+8K262975Arthrex Beaming SystemArthrex, Inc.20260—
+8K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+8K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+8K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+8K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+8K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+8K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+8K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+8K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+8K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+8K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+8K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+8K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+8K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+8K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+8K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+8K173135VariAx 2 SystemStryker GmbH201713—
+8K171060OrthoButton ALRiverpoint Medical20178—
+8K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+9K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+9K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+9K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+9K253538TeKBrace Knotless AnchorTheramicro20260—
+9K253695LigaMendRiverpoint Medical, LLC20260—
+9K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+9K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+9K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+9K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+9K243988RootMend MRRRiverpoint Medical, LLC20250—
+9K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+9K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+9K240194ProCinch, QuadCinchRiverpoint Medical20240—
+9K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+9K233552IDEAL ZiploopRiverpoint Medical20230—
+9K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+9K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+9K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+9K230212OrthoButton ALRiverpoint Medical, LLC20232—
+9K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+9K202399OrthoButton FLRiverpoint Medical20201—
+9K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+9K180500VariAx 2 SystemStryker GmbH201812—
+10K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+10K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+10K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+10K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—