510(k) Report

Devices descending from K974876

419 later devices reach Bionx Distal Radius Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K254176SinefixBAAT Medical Products B.V.20260—
+8K260405FiberTape ButtonArthrex, Inc.20260—
+8K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+8K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+8K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+8K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+8K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+8K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+8K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+8K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+8K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+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—
+8K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+8K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+8K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+8K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+8K233659Suture WingOsteonic Co., Ltd.20230—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+8K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+8K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+8K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+8K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+8K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+8K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+8K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+8K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+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—
+8K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+8K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+8K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+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—
+8K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+8K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+8K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+8K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+8K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+8K183331Parcus GFS BTBParcus Medical, LLC20193—
+8K173556Injection ScrewBiedermann Medtech, Inc.20180—
+8K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+8K172921Stryker Self-Punching ICONIXStryker20170—
+8K160655OrthoButton CLRiverpoint Medical20169—
+8K152711Parcus GFS NakedParcus Medical, LLC20154—
+8K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+8K140769Variax 2 SystemStryker Trauma AG201419—
+8K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+9K262975Arthrex Beaming SystemArthrex, Inc.20260—
+9K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+9K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+9K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+9K241912BiochargeNanofiber Solutions, LLC20240—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+9K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+9K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+9K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+9K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+9K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+9K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+9K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+9K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+9K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+9K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+9K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+9K173135VariAx 2 SystemStryker GmbH201713—
+9K171060OrthoButton ALRiverpoint Medical20178—
+9K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+10K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+10K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+10K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+10K253538TeKBrace Knotless AnchorTheramicro20260—
+10K253695LigaMendRiverpoint Medical, LLC20260—
+10K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+10K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+10K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+10K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+10K243988RootMend MRRRiverpoint Medical, LLC20250—
+10K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+10K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+10K240194ProCinch, QuadCinchRiverpoint Medical20240—
+10K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+10K233552IDEAL ZiploopRiverpoint Medical20230—
+10K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+10K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+10K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—