510(k) Report

Devices descending from K982347

262 later devices reach Depuy Ace Timax Pilon Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+6K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+6K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+6K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+6K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+6K183331Parcus GFS BTBParcus Medical, LLC20193—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K160655OrthoButton CLRiverpoint Medical20169—
+6K152711Parcus GFS NakedParcus Medical, LLC20154—
+6K150359Tensyn PlugDallen Medical, Inc.20150—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K254176SinefixBAAT Medical Products B.V.20260—
+7K253538TeKBrace Knotless AnchorTheramicro20260—
+7K253695LigaMendRiverpoint Medical, LLC20260—
+7K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+7K243988RootMend MRRRiverpoint Medical, LLC20250—
+7K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+7K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+7K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+7K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+7K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+7K192592Axis Plating SystemExtremity Medical, LLC20190—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+7K171060OrthoButton ALRiverpoint Medical20178—
+8K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+8K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+8K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K240194ProCinch, QuadCinchRiverpoint Medical20240—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K233552IDEAL ZiploopRiverpoint Medical20230—
+8K230212OrthoButton ALRiverpoint Medical, LLC20232—
+8K202399OrthoButton FLRiverpoint Medical20201—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+9K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123