510(k) Report

Devices descending from K961522

439 later devices reach Kirschner Wire (K-Wire) and Steinmann Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+6K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+7K261511Xpert AnkleNewclip Technics20260—
+7K260761APTUS Clavicle System 2.8Medartis AG20260—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+7K254182AsterOsteonic Co., Ltd.20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+7K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+7K243469SignexOsteonic Co., Ltd.20250—
+7K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+7K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+7K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+7K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+7K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+7K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+7K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+7K241539Activmotion SNewclip Technics20240—
+7K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+7K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+7K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+7K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+7K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+7K220966SinefixBAAT Medical Products B.V.20231—
+7K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+7K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+7K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+7K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+7K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+7K202307Activ FuseNewclip Technics20200—
+7K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+7K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+7K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+7K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+7K191972ARIX Wrist SystemJeil Medical Corporation20190—
+7K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+7K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+7K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+7K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+7K183331Parcus GFS BTBParcus Medical, LLC20193—
+7K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+7K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+7K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+7K160655OrthoButton CLRiverpoint Medical20169—
+7K152711Parcus GFS NakedParcus Medical, LLC20154—
+7K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+7K132502Variax 2 SystemStryker Trauma AG201321—
+7K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+8K254280F.A.S.T ScrewSteps Ortho20260—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+8K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+8K254215Arthrex Beaming SystemArthrex, Inc.20261—
+8K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+8K254176SinefixBAAT Medical Products B.V.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—
+8K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+8K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+8K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+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—
+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—
+8K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+8K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+8K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+8K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+8K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+8K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+8K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+8K171060OrthoButton ALRiverpoint Medical20178—
+8K140769Variax 2 SystemStryker Trauma AG201419—