FDA 510(k) Applications Submitted by Arthrex Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K232340 08/04/2023 Arthrex 2.4mm Knotless Hip SutureTak« Suture Anchor Arthrex Inc.
K182039 07/30/2018 Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay Arthrex Inc.
K173900 12/22/2017 Arthrex Univers Revers Modular Glenoid System Arthrex Inc.
K190707 03/19/2019 Arthrex SoftStitch Arthrex Inc.
K171020 04/05/2017 Arthrex Knotless SutureTak Anchor Arthrex Inc.
K182799 10/02/2018 Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads Arthrex Inc.
K203100 10/14/2020 Arthrex Eclipse Titanium Humeral Head Arthrex Inc.
K183194 11/19/2018 Arthrex Eclipse Shoulder Prosthesis System Arthrex Inc.
K173788 12/14/2017 Arthrex Corkscrew FT Arthrex Inc.
K173845 12/19/2017 Arthrex SwiveLock Arthrex Inc.
K170382 02/07/2017 Arthrex Compression Screws Arthrex Inc.
K170414 02/10/2017 Arthrex Univers Revers Apex Humeral Stems Arthrex Inc.
K171141 04/18/2017 Arthrex SwiveLock Anchors Arthrex Inc.
K191226 05/07/2019 Arthrex SwiveLock Suture Anchor Arthrex Inc.
K171365 05/09/2017 Arthrex Knee Systems Arthrex Inc.
K181555 06/13/2018 Arthrex Fracture Adapter Hemi Shoulder Prosthesis Arthrex Inc.
K171841 06/20/2017 Arthrex Shoulder System Arthrex Inc.
K212415 08/03/2021 Arthrex Modular Glenoid System-Titanium Glenosphere Arthrex Inc.
K173240 10/05/2017 Arthrex PushLock Arthrex Inc.
K243344 10/25/2024 Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures Arthrex Inc.
K250424 02/14/2025 Arthrex TightRope Soft Button, RT Arthrex Inc.
K230568 03/01/2023 FiberTak Suture Anchor Arthrex Inc.
K231330 05/08/2023 FiberTak« Suture Anchor Arthrex Inc.
K223284 10/25/2022 SutureLocÖ Implant Arthrex Inc.
K193523 12/19/2019 ArthrexVIP Web Portal Arthrex Inc.
K190645 03/13/2019 Arthrex NanoScope System Arthrex Inc.
K190921 04/09/2019 Arthrex Low Profile Screws Arthrex Inc.
K202582 09/08/2020 Arthrex SynergyID Endoscopic Imaging System Arthrex Inc.
K210050 01/08/2021 Augmented VaultLock Glenoid Arthrex Inc.
K190288 02/11/2019 Arthrex Tenodesis Button Arthrex Inc.
K200433 02/21/2020 iBalance UKA Tibial Tray Implant Arthrex Inc.
K220947 04/01/2022 Arthrex Knotless AC Repair Devices Arthrex Inc.
K200895 04/03/2020 Univers Revers Modular Glenoid System, Half Augment Baseplate Arthrex Inc.
K211074 04/12/2021 Univers Revers Modular Glenoid System, Standard Augment Baseplates Arthrex Inc.
K221232 04/29/2022 Univers Revers Humeral Cup Implant Arthrex Inc.
K191426 05/29/2019 FiberTak Button Arthrex Inc.
K181513 06/08/2018 Arthrex PushLock Tenodesis Anchor Arthrex Inc.
K222007 07/07/2022 Arthrex Virtual Implant Positioning (VIP) System Arthrex Inc.
K191960 07/23/2019 Arthrex Univers Revers Modular Glenoid System Arthrex Inc.
K192532 09/16/2019 Arthrex SwiveLock Anchor Arthrex Inc.
K233260 09/29/2023 Univers Revers CA Head and Adapter Arthrex Inc.
K193372 12/05/2019 Univers Revers Modular Glenoid System (Augemented baseplates) Arthrex Inc.
K193575 12/23/2019 Arthrex SutureTape Arthrex Inc.
K243995 12/26/2024 Arthrex Humeral Plating System and Cerclage Button Arthrex Inc.
K240815 03/25/2024 Arthrex Cannulated Screw System Arthrex Inc.
K201749 06/26/2020 Arthrex SwiveLock Anchor Arthrex Inc.
K202444 08/26/2020 Knotless TensionTight Button Implant System Arthrex Inc.
K203268 11/05/2020 Arthrex FiberTak Suture Anchor Arthrex Inc.
K200341 02/11/2020 Arthrex FiberTak Suture Anchor Arthrex Inc.
K180662 03/14/2018 Arthrex FastThread Interference Screw Arthrex Inc.
K190728 03/21/2019 Arthrex SwiveLock Anchors Arthrex Inc.
K180768 03/23/2018 Arthrex SwiveLock Anchors Arthrex Inc.
K202535 09/01/2020 Arthrex FastThread Interference Screw Arthrex Inc.
K192441 09/06/2019 Arthrex SwiveLock Anchors Arthrex Inc.
K193157 11/14/2019 Arthrex 3.9mm Corkscrew Suture Anchor Arthrex Inc.
K193503 12/18/2019 Arthrex SwiveLock Suture Anchor Arthrex Inc.
K230433 02/17/2023 Arthrex Knotless FiberTak Suture Anchor Arthrex Inc.
K221099 04/14/2022 Arthrex Self-Punching PushLock Suture Anchor Arthrex Inc.
K201786 06/30/2020 Arthrex Mini Hip PushLock Arthrex Inc.
K203495 11/27/2020 Arthrex SwiveLock Anchor Arthrex Inc.
K243742 12/04/2024 Arthrex DynaNite Nitinol Staples Arthrex Inc.
K222161 07/20/2022 Arthrex Knotless FiberTak Biceps Suture Anchor Arthrex Inc.
K221485 05/23/2022 Arthrex FiberTape and TigerTape Cerclage Sutures Arthrex Inc.
K202581 09/08/2020 Arthrex TightRope II Arthrex Inc.
K231113 04/19/2023 Arthrex FiberTak Suture Anchor Arthrex Inc.
K231857 06/23/2023 Arthrex TightRope II Arthrex Inc.
K232742 09/07/2023 Arthrex FiberTak Suture Anchor Arthrex Inc.
K221128 04/18/2022 Arthrex ACL TightRope«, PCL TightRope«, and TightRope« II Arthrex Inc.
K221354 05/10/2022 Arthrex SutureTape Arthrex Inc.
K221396 05/13/2022 Arthrex FiberTak Suture Anchor Arthrex Inc.
K213213 09/29/2021 Arthrex Vortex Threaded Bone Marrow Recovery Needle Arthrex Inc.
K251145 04/14/2025 Arthrex PushLock Suture Anchors Arthrex Inc.
K200068 01/13/2020 Arthrex DynaNite K-Wire Arthrex Inc.
K210994 04/02/2021 Arthrex Beveled FT Screws Arthrex Inc.
K201677 06/19/2020 Arthrex Mesh Plates Arthrex Inc.
K203180 10/26/2020 Arthrex DynaNite Nitinol Staples Arthrex Inc.
K213644 11/18/2021 Arthrex Knotless Mini TightRopes Arthrex Inc.
K180118 01/16/2018 Arthrex NanoSuture Anchor Arthrex Inc.
K190287 02/11/2019 Arthrex DynaNite« PIP (Hammertoe) Implant Arthrex Inc.
K220839 03/23/2022 Arthrex Compression FT Pins Arthrex Inc.
K221031 04/07/2022 Arthrex DualCompression Hindfoot Fusion Nail Implant System Arthrex Inc.
K201235 05/07/2020 Arthrex MaxForce MTP Compression Plates and Screws Arthrex Inc.
K191326 05/16/2019 Arthrex Mini Comprehensive Fixation System û 1.4mm & 1.6mm Module Arthrex Inc.
K201522 06/08/2020 Arthrex Syndesmosis TightRope XP Buttress Plate Implant System Arthrex Inc.
K191651 06/20/2019 Arthrex Nano SwiveLock Suture Anchor Arthrex Inc.
K172052 07/06/2017 Arthrex DynaNite Nitinol Staple Arthrex Inc.
K182361 08/30/2018 Arthrex Compression FT Screws Arthrex Inc.
K193156 11/14/2019 Arthrex Mini Comprehensive Fixation System - 1.0mm Screws Arthrex Inc.
K193345 12/03/2019 Arthrex DynaNite Compression Plate Arthrex Inc.
K183395 12/07/2018 Arthrex 2.5 mm Tenodesis Screw Arthrex Inc.
K203834 12/30/2020 Arthrex Patella SuturePlates Arthrex Inc.
K191344 05/20/2019 Arthrex Mini Comprehensive Fixation System û 2.0mm & 2.4mm Module Arthrex Inc.
K250596 02/28/2025 Arthrex FiberTak Suture Anchor Arthrex Inc.
K232755 09/08/2023 Arthrex FiberTape and TigerTape Cerclage Sutures Arthrex Inc.
K201132 04/28/2020 Arthrex Compression Screws Arthrex Inc.
K203239 11/03/2020 Arthrex Low Profile Screws Arthrex Inc.
K203294 11/09/2020 Arthrex Pilon Fusion System Arthrex Inc.
K220880 03/25/2022 Arthrex BioSuture Arthrex Inc.
K220937 03/31/2022 Arthrex Mini Fragment System Arthrex Inc.
K242079 07/16/2024 Arthrex Elbow Fracture Plating System Arthrex Inc.
K222244 07/26/2022 Arthrex 3.5 mm Locking Compression Plates Arthrex Inc.
K222267 07/28/2022 Arthrex 2.4 mm Volar Distal Radius Plate System Arthrex Inc.
K213837 12/09/2021 Arthrx Fracture Plates Arthrex Inc.
K243890 12/18/2024 Arthrex Intramedullary Nails Arthrex Inc.
K183628 12/26/2018 Arthrex TensionLoc System Arthrex Inc.
K230366 02/10/2023 Arthrex Univers Revers Monoblock Stem Size 4/33 Arthrex Inc.
K251453 05/12/2025 Arthrex iBalance Partial Knee System Arthrex Inc.
K222263 07/28/2022 Arthrex Self Punching SwiveLock Suture Anchors Arthrex Inc.
K243480 11/08/2024 SuturePatch Tissue Reinforcement Arthrex Inc.
K230904 03/31/2023 Arthrex Virtual Implant Positioning (VIP) System Arthrex Inc.


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