510(k) Report

Devices descending from K953644

438 later devices reach Volar Distal Radius Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+8K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+8K171465Stryker Self-Punching ICONIXStryker20171—
+8K162198GFS UltimateParcus Medical, LLC20168—
+8K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+8K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+8K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+8K140328CMC Mini TightropeArthrex, Inc.20146—
+8K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+8K132502Variax 2 SystemStryker Trauma AG201321—
+8K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+8K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+8K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+9K254280F.A.S.T ScrewSteps Ortho20260—
+9K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+9K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+9K254215Arthrex Beaming SystemArthrex, Inc.20261—
+9K252246Leforte MMF SystemJeil Medical Corporation20260—
+9K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+9K254176SinefixBAAT Medical Products B.V.20260—
+9K260405FiberTape ButtonArthrex, Inc.20260—
+9K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+9K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+9K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+9K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+9K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+9K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+9K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+9K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+9K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+9K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+9K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+9K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+9K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+9K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+9K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+9K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+9K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+9K233659Suture WingOsteonic Co., Ltd.20230—
+9K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+9K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+9K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+9K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+9K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+9K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+9K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+9K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+9K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+9K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+9K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+9K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+9K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+9K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+9K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+9K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+9K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+9K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+9K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+9K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+9K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+9K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+9K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+9K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+9K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+9K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+9K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+9K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+9K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+9K183331Parcus GFS BTBParcus Medical, LLC20193—
+9K173556Injection ScrewBiedermann Medtech, Inc.20180—
+9K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+9K172921Stryker Self-Punching ICONIXStryker20170—
+9K160655OrthoButton CLRiverpoint Medical20169—
+9K152711Parcus GFS NakedParcus Medical, LLC20154—
+9K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+9K140769Variax 2 SystemStryker Trauma AG201419—
+9K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+10K262975Arthrex Beaming SystemArthrex, Inc.20260—
+10K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+10K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+10K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+10K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+10K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+10K241912BiochargeNanofiber Solutions, LLC20240—
+10K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+10K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+10K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+10K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+10K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+10K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+10K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+10K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+10K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+10K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+10K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+10K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+10K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+10K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+10K173135VariAx 2 SystemStryker GmbH201713—
+10K171060OrthoButton ALRiverpoint Medical20178—