Arthrex, Inc.
Medical device manufacturer in Naples, FL.
353510(k) clearances
0PMA approvals
28recalls
Device types
- MBI Fastener, Fixation, Nondegradable, Soft… 52
- HWC Screw, Fixation, Bone 46
- MAI Fastener, Fixation, Biodegradable, Soft… 46
- HRS Plate, Fixation, Bone 39
- HRX Arthroscope 27
- GAT Suture, Nonabsorbable, Synthetic… 19
- HTN Washer, Bolt Nut 16
- KWS Prosthesis, Shoulder, Semi-Constrained… 15
- HTY Pin, Fixation, Smooth 13
- PHX Shoulder Prosthesis, Reverse Configuration 11
- GCJ Laparoscope, General & Plastic Surgery 9
- JDR Staple, Fixation, Bone 6
- HSB Rod, Fixation, Intramedullary And Accessories 6
- HSD Prosthesis, Shoulder, Hemi-, Humeral… 5
- MBH Prosthesis, Knee, Patello/Femorotibial… 4
- JWH Prosthesis, Knee, Patellofemorotibial… 4
- JDQ Cerclage, Fixation 3
- HSX Prosthesis, Knee, Femorotibial… 3
- QHE Shoulder Arthroplasty Implantation System 3
- GEI Electrosurgical, Cutting & Coagulation &… 2
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | 09/01/2026SE |
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | 08/07/2026SE |
| K260624 | Arthrex Radial Head Replacement SystemKWI · Traditional | 07/30/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | 06/26/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | 06/25/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | 05/28/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | 05/08/2026SE |
| K260561 | Arthrex FiberTak Suture AnchorMBI · Special | 03/20/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | 03/20/2026SE |
| K260405 | FiberTape ButtonMBI · Special | 03/09/2026SE |
| K252196 | Arthrex FibuLock Nail SystemHSB · Traditional | 03/05/2026SE |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonHRS · Special | 03/03/2026SE |
| K254229 | Arthrex Nano FiberTak Suture AnchorMBI · Traditional | 03/02/2026SE |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating SystemHRS · Traditional | 01/21/2026SE |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesHRS · Traditional | 01/12/2026SE |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmMBI · Special | 12/30/2025SE |
| K253727 | Syndesmosis TightRope PROHTN · Special | 12/22/2025SE |
| K252314 | Arthrex SutureTak Suture AnchorMBI · Traditional | 10/29/2025SE |
| K251994 | Arthrex Synergy Vision Imaging SystemGCJ · Traditional | 10/16/2025SE |
| K251690 | Arthrex SpeedFLEX ImplantOWY · Traditional | 09/30/2025SE |
| K251809 | Arthrex FiberTak Suture AnchorMBI · Traditional | 07/18/2025SE |
| K251145 | Arthrex PushLock Suture AnchorsMBI · Traditional | 07/10/2025SE |
| K251453 | Arthrex iBalance Partial Knee SystemHSX · Traditional | 07/01/2025SE |
| K243480 | SuturePatch Tissue ReinforcementOWX · Traditional | 05/29/2025SE |
| K250920 | Arthrex Spine Compression FT ScrewMRW · Traditional | 05/22/2025SE |
| K243602 | Arthrex Spine EndoscopeHRX · Traditional | 05/16/2025SE |
| K250728 | Arthrex Synergy Vision Endoscopic Imaging SystemGCJ · Traditional | 05/05/2025SE |
| K250596 | Arthrex FiberTak Suture AnchorMBI · Special | 03/28/2025SE |
| K243995 | Arthrex Humeral Plating System and Cerclage ButtonHRS · Traditional | 03/26/2025SE |
| K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorMAI · Special | 03/14/2025SE |
| K250424 | Arthrex TightRope Soft Button, RTMBI · Special | 03/11/2025SE |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…JDQ · Traditional | 02/20/2025SE |
| K243742 | Arthrex DynaNite Nitinol StaplesJDR · Traditional | 01/31/2025SE |
| K243008 | Arthrex NanoScope SystemGCJ · Traditional | 01/22/2025SE |
| K243890 | Arthrex Intramedullary NailsHSB · Special | 01/13/2025SE |
| K243195 | Arthrex SS VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | 01/10/2025SE |
| K242079 | Arthrex Elbow Fracture Plating SystemHRS · Traditional | 11/14/2024SE |
| K242554 | Arthrex VAL and VAL KreuLock Compression Screw SystemHRS · Traditional | 10/21/2024SE |
| K241097 | Arthrex Virtual Implant Positioning (VIP) System SoftwareQHE · Traditional | 10/02/2024SE |
| K241592 | Arthrex VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | 08/31/2024SE |
| K241361 | Arthrex Synergy Vision Endoscopic Imaging SystemGCJ · Traditional | 07/25/2024SE |
| K240815 | Arthrex Cannulated Screw SystemHWC · Traditional | 06/13/2024SE |
| K233971 | Arthrex AlloSync PushLock Suture AnchorMAI · Traditional | 06/04/2024SE |
| K241235 | Arthrex TightRope IIMBI · Special | 05/29/2024SE |
| K233260 | Univers Revers CA Head and AdapterHSD · Traditional | 02/12/2024SE |
| K233451 | Arthrex Synergy Vision Endoscopic Imaging SystemGCJ · Traditional | 01/18/2024SE |
| K232973 | Arthrex Knee FiberTak® Button Suture AnchorMBI · Traditional | 11/15/2023SE |
| K232742 | Arthrex FiberTak Suture AnchorMBI · Traditional | 11/03/2023SE |
| K232897 | Arthrex Small External Fixation SystemKTT · Special | 10/18/2023SE |
| K232755 | Arthrex FiberTape and TigerTape Cerclage SuturesHTN · Special | 10/06/2023SE |
| K230513 | Arthrex Univers Apex OptiFit Humeral StemKWS · Traditional | 09/26/2023SE |
| K232340 | Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorMBI · Special | 09/01/2023SE |
| K230976 | Arthrex Radiopaque FiberTape Cerclage suturesJDQ · Traditional | 08/24/2023SE |
| K231857 | Arthrex TightRope IIMBI · Traditional | 08/08/2023SE |
| K230257 | Arthrex Intramedullary NailsHSB · Traditional | 07/17/2023SE |
| K230904 | Arthrex Virtual Implant Positioning (VIP) SystemQHE · Traditional | 06/22/2023SE |
| K231330 | FiberTak® Suture AnchorMBI · Special | 06/01/2023SE |
| K231113 | Arthrex FiberTak Suture AnchorMBI · Special | 05/18/2023SE |
| K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33PHX · Traditional | 04/10/2023SE |
| K230568 | FiberTak Suture AnchorMBI · Special | 04/01/2023SE |
| K230435 | Arthrex 3.9 mm SwiveLock AnchorMAI · Special | 03/17/2023SE |
| K230433 | Arthrex Knotless FiberTak Suture AnchorMBI · Special | 03/10/2023SE |
| K222007 | Arthrex Virtual Implant Positioning (VIP) SystemQHE · Traditional | 03/08/2023SE |
| K223284 | SutureLoc ImplantMBI · Traditional | 02/02/2023SE |
| K221396 | Arthrex FiberTak Suture AnchorMBI · Traditional | 12/22/2022SE |
| K221031 | Arthrex DualCompression Hindfoot Fusion Nail Implant SystemHSB · Traditional | 12/20/2022SE |
| K220880 | Arthrex BioSutureGAT · Special | 10/27/2022SE |
| K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIMAI · Traditional | 10/05/2022SE |
| K222267 | Arthrex 2.4 mm Volar Distal Radius Plate SystemHRS · Traditional | 10/03/2022SE |
| K222244 | Arthrex 3.5 mm Locking Compression PlatesHRS · Traditional | 09/30/2022SE |
| K220839 | Arthrex Compression FT PinsHWC · Traditional | 09/19/2022SE |
| K222078 | Arthrex SoftStitchGAT · Traditional | 09/14/2022SE |
| K221354 | Arthrex SutureTapeGAT · Special | 09/09/2022SE |
| K222263 | Arthrex Self Punching SwiveLock Suture AnchorsMAI · Special | 08/26/2022SE |
| K221485 | Arthrex FiberTape and TigerTape Cerclage SuturesHTN · Traditional | 08/22/2022SE |
| K222161 | Arthrex Knotless FiberTak Biceps Suture AnchorMBI · Special | 08/11/2022SE |
| K220937 | Arthrex Mini Fragment SystemHRS · Traditional | 06/29/2022SE |
| K220947 | Arthrex Knotless AC Repair DevicesHTN · Traditional | 06/06/2022SE |
| K221232 | Univers Revers Humeral Cup ImplantHSD · Special | 05/19/2022SE |
| K221099 | Arthrex Self-Punching PushLock Suture AnchorMAI · Special | 05/13/2022SE |
| K213837 | Arthrx Fracture PlatesHRS · Traditional | 05/02/2022SE |
| K213644 | Arthrex Knotless Mini TightRopesHTN · Special | 12/17/2021SE |
| K213213 | Arthrex Vortex Threaded Bone Marrow Recovery NeedleKNW · Traditional | 11/19/2021SE |
| K212415 | Arthrex Modular Glenoid System-Titanium GlenospherePHX · Traditional | 11/17/2021SE |
| K212146 | Arthrex LoopLoc Knotless SutureGAT · Traditional | 10/25/2021SE |
| K211074 | Univers Revers Modular Glenoid System, Standard Augment BaseplatesPHX · Traditional | 09/02/2021SE |
| K202582 | Arthrex SynergyID Endoscopic Imaging SystemGCJ · Traditional | 07/22/2021SE |
| K210050 | Augmented VaultLock GlenoidKWS · Traditional | 06/07/2021SE |
| K210994 | Arthrex Beveled FT ScrewsHWC · Traditional | 06/01/2021SE |
| K203495 | Arthrex SwiveLock AnchorMAI · Traditional | 04/19/2021SE |
| K203834 | Arthrex Patella SuturePlatesHRS · Traditional | 03/25/2021SE |
| K203294 | Arthrex Pilon Fusion SystemHRS · Traditional | 02/03/2021SE |
| K203239 | Arthrex Low Profile ScrewsHWC · Traditional | 12/30/2020SE |
| K203180 | Arthrex DynaNite Nitinol StaplesJDR · Traditional | 12/16/2020SE |
| K203268 | Arthrex FiberTak Suture AnchorMBI · Special | 11/27/2020SE |
| K203100 | Arthrex Eclipse Titanium Humeral HeadPKC · Special | 11/20/2020SE |
| K202535 | Arthrex FastThread Interference ScrewMAI · Special | 11/18/2020SE |
| K202444 | Knotless TensionTight Button Implant SystemMBI · Special | 11/17/2020SE |
| K202581 | Arthrex TightRope IIMBI · Traditional | 11/04/2020SE |
| K190707 | Arthrex SoftStitchGAT · Traditional | 10/02/2020SE |
| K201134 | Arthrex NanoScope SystemGCJ · Traditional | 09/04/2020SE |
| K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemHTN · Traditional | 09/03/2020SE |
| K201677 | Arthrex Mesh PlatesHRS · Traditional | 09/02/2020SE |
| K201749 | Arthrex SwiveLock AnchorMAI · Traditional | 08/21/2020SE |
| K200895 | Univers Revers Modular Glenoid System, Half Augment BaseplatePHX · Traditional | 08/13/2020SE |
| K201786 | Arthrex Mini Hip PushLockMAI · Special | 07/30/2020SE |
| K201132 | Arthrex Compression ScrewsHRS · Traditional | 07/27/2020SE |
| K193575 | Arthrex SutureTapeGAT · Traditional | 07/24/2020SE |
| K201542 | Arthrex Eclipse Shoulder Prosthesis SystemPKC · Special | 07/08/2020SE |
| K193345 | Arthrex DynaNite Compression PlateHRS · Traditional | 07/08/2020SE |
| K201235 | Arthrex MaxForce MTP Compression Plates and ScrewsHRS · Traditional | 07/06/2020SE |
| K200068 | Arthrex DynaNite K-WireHTY · Traditional | 06/29/2020SE |
| K193523 | ArthrexVIP Web PortalLLZ · Special | 04/30/2020SE |
| K200433 | iBalance UKA Tibial Tray ImplantHSX · Special | 03/17/2020SE |
| K200341 | Arthrex FiberTak Suture AnchorMBI · Special | 03/12/2020SE |
| K193156 | Arthrex Mini Comprehensive Fixation System - 1.0mm ScrewsHWC · Traditional | 02/10/2020SE |
| K193503 | Arthrex SwiveLock Suture AnchorMAI · Special | 01/15/2020SE |
| K193372 | Univers Revers Modular Glenoid System (Augemented baseplates)PHX · Special | 01/10/2020SE |
| K191960 | Arthrex Univers Revers Modular Glenoid SystemPHX · Special | 12/23/2019SE |
| K193157 | Arthrex 3.9mm Corkscrew Suture AnchorMAI · Special | 12/12/2019SE |
| K191426 | FiberTak ButtonMBI · Special | 11/26/2019SE |
| K191651 | Arthrex Nano SwiveLock Suture AnchorHWC · Traditional | 11/06/2019SE |
| K190921 | Arthrex Low Profile ScrewsHWC · Traditional | 10/30/2019SE |
| K192532 | Arthrex SwiveLock AnchorMAI · Special | 10/19/2019SE |
| K192441 | Arthrex SwiveLock AnchorsMAI · Special | 10/17/2019SE |
| K190953 | Arthrex Minimally Invasive Ankle Fusion PlateHRS · Traditional | 10/16/2019SE |
| K191326 | Arthrex Mini Comprehensive Fixation System 1.4mm & 1.6mm ModuleHRS · Traditional | 10/15/2019SE |
| K191344 | Arthrex Mini Comprehensive Fixation System 2.0mm & 2.4mm ModuleHRS · Traditional | 10/03/2019SE |
| K190288 | Arthrex Tenodesis ButtonMBI · Traditional | 09/13/2019SE |
| K183194 | Arthrex Eclipse Shoulder Prosthesis SystemQHQ · Traditional | 07/26/2019SE |
| K190645 | Arthrex NanoScope SystemGCJ · Traditional | 07/05/2019SE |
| K191226 | Arthrex SwiveLock Suture AnchorMAI · Special | 06/11/2019SE |
| K190287 | Arthrex DynaNite® PIP (Hammertoe) ImplantHTY · Traditional | 05/03/2019SE |
| K190728 | Arthrex SwiveLock AnchorsMBI · Special | 04/17/2019SE |
| K183395 | Arthrex 2.5 mm Tenodesis ScrewHWC · Traditional | 04/17/2019SE |
| K183628 | Arthrex TensionLoc SystemHWC · Traditional | 03/26/2019SE |
| K182799 | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsKWS · Traditional | 03/08/2019SE |
| K181555 | Arthrex Fracture Adapter Hemi Shoulder ProsthesisKWS · Traditional | 12/21/2018SE |
| K182361 | Arthrex Compression FT ScrewsHWC · Traditional | 12/18/2018SE |
| K180768 | Arthrex SwiveLock AnchorsMAI · Traditional | 12/14/2018SE |
| K182039 | Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayPHX · Traditional | 09/28/2018SE |
| K181769 | Arthrex FiberTak Suture AnchorMBI · Traditional | 09/21/2018SE |
| K181513 | Arthrex PushLock Tenodesis AnchorMBI · Special | 08/30/2018SE |
| K173845 | Arthrex SwiveLockMBI · Traditional | 08/06/2018SE |
| K173656 | Arthrex FibuLock NailHSB · Special | 07/26/2018SE |
| K180594 | Knotless SutureTak AnchorsMAI · Traditional | 06/22/2018SE |
| K180662 | Arthrex FastThread Interference ScrewMAI · Special | 05/22/2018SE |
| K173900 | Arthrex Univers Revers Modular Glenoid SystemPHX · Traditional | 04/20/2018SE |
| K171841 | Arthrex Shoulder SystemKWS · Traditional | 03/29/2018SE |
| K172371 | Arthrex UNIVERS REVERS COATED BASEPLATEPHX · Traditional | 03/22/2018SE |
| K173788 | Arthrex Corkscrew FTMAI · Special | 03/01/2018SE |
| K180118 | Arthrex NanoSuture AnchorMBI · Special | 02/12/2018SE |
| K173240 | Arthrex PushLockMAI · Traditional | 01/16/2018SE |
| K170414 | Arthrex Univers Revers Apex Humeral StemsPHX · Traditional | 12/14/2017SE |
| K172052 | Arthrex DynaNite Nitinol StapleJDR · Traditional | 12/13/2017SE |
| K170206 | Arthrex FiberTape CerclageJDQ · Traditional | 11/15/2017SE |
| K171365 | Arthrex Knee SystemsMBH · Traditional | 11/07/2017SE |
| K170547 | Arthrex Mesh Plate SystemHRS · Traditional | 09/01/2017SE |
| K170326 | dynaMX Intramedullary ImplantHTY · Traditional | 07/20/2017SE |
| K171296 | SutureTapeGAT · Special | 05/26/2017SE |
| K171020 | Arthrex Knotless SutureTak AnchorMBI · Traditional | 05/16/2017SE |
| K170382 | Arthrex Compression ScrewsHWC · Special | 05/11/2017SE |
| K171141 | Arthrex SwiveLock AnchorsMAI · Special | 05/04/2017SE |
| K161060 | Arthrex iBalance UKA System Vitamin E Tibial BearingHSX · Special | 12/15/2016SE |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis SystemHSD · Traditional | 11/21/2016SE |
| K161581 | Arthrex Synergy RF SystemGEI · Traditional | 09/09/2016SE |
| K161108 | Arthrex VaultLock GlenoidKWS · Special | 08/29/2016SE |
| K160319 | FiberTak DRMBI · Special | 05/10/2016SE |
| K151527 | Arthrex Univers Revers CA Heads and AdaptersHSD · Traditional | 04/19/2016SE |
| K160461 | Arthrex iBalance BiCompartmental Arthroplasty SystemKRR · Traditional | 04/12/2016SE |
| K151342 | Arthrex SwiveLock AnchorsMAI · Traditional | 03/24/2016SE |
| K151092 | Arthrex Short Suture AnchorsMBI · Traditional | 02/23/2016SE |
| K153586 | Arthrex iBalance TKA SystemMBH · Traditional | 02/19/2016SE |
| K153218 | Arthrex Synergy UHD4 SystemGCJ · Traditional | 02/12/2016SE |
| K153115 | Arthrex Univers Apex, Size 5 StemKWS · Special | 11/23/2015SE |
| K152252 | Arthrex iBalance TKA SystemMBH · Traditional | 11/16/2015SE |
| K152382 | Arthrex iBalance TKA SystemJWH · Special | 11/12/2015SE |
| K151732 | Arthrex Fracture PlatesHRS · Special | 08/28/2015SE |
| K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture…MBI · Traditional | 08/20/2015SE |
| K143745 | Arthrex Corkscrew and SwiveLock Suture AnchorsMBI · Traditional | 07/02/2015SE |
| K151230 | Arthrex FiberTak AnchorsMBI · Special | 06/19/2015SE |
| K151078 | Arthrex RetroFusion ScrewHWC · Special | 05/15/2015SE |
| K150456 | Arthrex Plates, Screws, and StaplesHRS · Special | 04/29/2015SE |
| K143702 | Arthrex Blunt Tip Screws with Fiber TapeHTY · Traditional | 04/09/2015SE |
| K143749 | Arthrex Distal Radius SystemHRS · Traditional | 04/03/2015SE |
| K143614 | Arthrex Low Profile ScrewsHWC · Special | 01/16/2015SE |
| K143139 | Arthrex Fracture SystemHRS · Special | 01/16/2015SE |
| K140855 | Arthrex Suturetak Suture AnchorsMAI · Traditional | 12/18/2014SE |
| K142863 | Univers Rivers Shoulder Prosthesis SystemPHX · Traditional | 11/25/2014SE |
| K143047 | Arthrex iBalance Patella Implant, DomeJWH · Special | 11/19/2014SE |
| K141635 | Arthrex Ibalance Tka SystemMBH · Traditional | 09/03/2014SE |
| K141735 | Arthrex Ankle Fusion Plating SystemHRS · Special | 08/15/2014SE |
| K140476 | Arthrex Fibertak Suture AnchorMBI · Traditional | 08/13/2014SE |
| K141577 | Arthrex Pip DartHTY · Special | 07/18/2014SE |
| K141478 | Arthrex Fracture Plates and ScrewsHRS · Special | 07/08/2014SE |
| K140328 | CMC Mini TightropeHTN · Special | 03/10/2014SE |
| K133854 | Arthrex Ibalance Tka SystemJWH · Special | 02/27/2014SE |
| K140019 | Arthrex BiosutureGAT · Special | 01/30/2014SE |
| K133275 | Mini TightropeHTN · Traditional | 01/30/2014SE |
| K133342 | Arthrex Ibalance Tka SystemJWH · Special | 12/17/2013SE |
| K132217 | Arthrex Compression FT ScrewsHWC · Traditional | 11/25/2013SE |
| K130675 | Arthrex Univers II Ca HeadsHSD · Traditional | 10/30/2013SE |
| K131633 | Arthrex Univers ApexKWS · Traditional | 09/27/2013SE |
| K130510 | Arthrex Compression PlatesHRS · Traditional | 09/25/2013SE |
| K132043 | Arthrex SpeedcinchGAT · Special | 07/31/2013SE |
| K131474 | Arthrex Distal Radius Plate SystemHRS · Traditional | 07/03/2013SE |
| K130129 | Univers Revers Shoulder Prosthesis SystemKWS · Traditional | 05/31/2013SE |
| K130458 | Knotless Fibertak Suture AnchorMBI · Traditional | 05/03/2013SE |
| K123241 | Arthrex Fracture PlatesHRS · Traditional | 04/05/2013SE |
| K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…MBI · Traditional | 12/21/2012SE |
| K122374 | Arthrex Suture (Uhmwpe)GAT · Special | 09/25/2012SE |
| K121124 | Arthrex Mixing and Delivery SystemFMF · Traditional | 05/16/2012SE |
| K112899 | Arthrex Bio-SutureGAT · Traditional | 04/06/2012SE |
| K120540 | BioboltMAI · Special | 03/20/2012SE |
| K120044 | Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL Glenoid-KeeledKWS · Special | 03/08/2012SE |
| K120155 | Arthrex Knotless Suturetak AnchorMBI · Special | 02/17/2012SE |
| K112437 | Arthrex Fracture SystemHTN · Traditional | 12/21/2011SE |
| K112990 | Acl Tightrope,Acl Tightrope Duuble BundleHTY · Traditional | 12/19/2011SE |
| K112040 | Arthrex Biocomposite TransfixMAI · Special | 12/15/2011SE |
| K112237 | Microsuture AnchorsHWC · Special | 09/02/2011SE |
| K111661 | Arthrex Scapholunate AnchorMBI · Special | 08/19/2011SE |
| K111253 | Arthrex Distal Extremity Plate SystemHRS · Traditional | 08/02/2011SE |
| K110123 | PCL TightropeHTY · Traditional | 04/28/2011SE |
| K110660 | Arthrex Biocomposite SuturetakMAI · Special | 03/31/2011SE |
| K103705 | Low Profile ScrewsHWC · Traditional | 03/18/2011SE |
| K101823 | Arthrex Swivelock AnchorsMAI · Traditional | 01/07/2011SE |
| K103060 | Arthrex Tibial GraftboltMBI · Special | 01/05/2011SE |
| K101837 | Acl Tightrope Double BundleHTY · Traditional | 12/28/2010SE |
| K103466 | Arthrex Univers II Shoulder ProsthesisKWS · Special | 12/22/2010SE |
| K101679 | Arthrex Pushlock AnchorsMAI · Traditional | 10/22/2010SE |
| K091018 | Arthrex BiowireGAS · Traditional | 07/30/2010SE |
| K100652 | Acl TightropeHTY · Special | 06/23/2010SE |
| K093912 | Arthrex Tibial GraftboltMBI · Traditional | 03/18/2010SE |
| K091844 | Arthrex Bio-Composite Suturetak AnchorsMAI · Special | 08/28/2009SE |
| K090107 | Mini TightropeHTN · Traditional | 08/06/2009SE |
| K083707 | Arthrex Dual Wave Arthroscopy Fluid Management DeviceHRX · Traditional | 08/03/2009SE |
| K083435 | Arthrex Univers II Shoulder Pegged GlenoidKWS · Special | 06/26/2009SE |
| K083007 | ProwickFRO · Special | 04/08/2009SE |
| K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…MAI · Traditional | 01/23/2009SE |
| K082999 | Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral DartMAI · Traditional | 12/30/2008SE |
| K080111 | Arthrex Compression StapleJDR · Traditional | 02/13/2008SE |
| K073149 | Meniscal CinchGAT · Traditional | 02/11/2008SE |
| K071456 | Arthrex Prostop Plus Arthroereisis Subtalar ImplantMAI · Traditional | 01/17/2008SE |
| K072378 | Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…FRO · Traditional | 11/09/2007SE |
| K071032 | Arthrex Univers II Shoulder ProsthesisKWS · Special | 08/20/2007SE |
| K071978 | Mini Tightrope FT Repair KitHTN · Special | 08/15/2007SE |
| K071176 | Modification to: Arthrex Interference ScrewMAI · Traditional | 08/03/2007SE |
| K071622 | Arthrex FiberwireGAT · Special | 07/03/2007SE |
| K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…HWC · Special | 06/29/2007SE |
| K063719 | Arthrex Crosspin, Model AR-1964PHTY · Traditional | 03/06/2007SE |
| K063058 | Arthrex Anatoemic Phalangeal ProsthesisKWD · Traditional | 01/03/2007SE |
| K063479 | Arthrex PushlockHWC · Special | 12/13/2006SE |
| K062466 | Arthrex Interference ScrewMAI · Traditional | 11/29/2006SE |
| K061925 | Mini Tightrope Repair Kit, Model AR-8911DSHTN · Traditional | 10/31/2006SE |
| K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyHWC · Traditional | 10/19/2006SE |
| K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMHRS · Special | 09/29/2006SE |
| K062365 | Arthrex Aspirate KitFMF · Traditional | 09/29/2006SE |
| K062679 | Arthrex Corkscrew FT III Suture Anchor with Three #2 SuturesHWC · Special | 09/27/2006SE |
| K061665 | Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTHWC · Special | 07/25/2006SE |
| K060478 | Arthrex Bio-Compression ScrewHWC · Traditional | 05/19/2006SE |
| K053543 | Arthrex Arthoeresis ImplantHWC · Traditional | 04/03/2006SE |
| K053338 | Arthrex Titanium and Bio-Degradable (Polymer) ImplantsHWC · Traditional | 01/26/2006SE |
| K052776 | Tightrope Acromioclavicular (Ac) Device, Titanium, Stainless Steel , Models AR-2257…HTN · Traditional | 12/13/2005SE |
| K052901 | Arthrex TensionlokHRS · Special | 12/12/2005SE |
| K052387 | Arthrex Fingershield Finger Guard, Model AR-7199-XXLZB · Traditional | 11/29/2005SE |
| K052607 | Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed…HWC · Traditional | 11/07/2005SE |
| K052736 | Arthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XTHTY · Traditional | 11/03/2005SE |
| K052614 | Low Profile Plate and Screw SystemHRS · Special | 09/28/2005SE |
| K051726 | Arthrex Tenodesis FamilyHWC · Traditional | 09/27/2005SE |
| K051219 | PushlockMAI · Special | 06/29/2005SE |
| K050259 | Arthrex Bio-PinHTY · Traditional | 05/27/2005SE |
| K050749 | Arthrex Tak FamilyHWC · Traditional | 05/12/2005SE |
| K050358 | Artherx Corkscrew FT II Suture AnchorHWC · Special | 04/15/2005SE |
| K050634 | Modification to: Arthrex V-TakHWC · Special | 03/21/2005SE |
| K043145 | Bi-Cortical Bio-Post and Washer, Model AR-1367BHTN · Traditional | 02/18/2005SE |
| K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…HTN · Traditional | 02/16/2005SE |
| K043337 | Arthrex Bio-Corkscrew FT Suture AnchorHWC · Special | 12/14/2004SE |
| K041553 | Arthrex Suture Grafting KitGAT · Traditional | 12/10/2004SE |
| K041356 | Arthrex Tenodesis Screw FamilyHWC · Traditional | 11/04/2004SE |
| K041189 | Arthrex Trimit FamilyHWC · Traditional | 11/04/2004SE |
| K041965 | Arthrex Humeral Fracture Plates and ScrewsHRS · Traditional | 09/08/2004SE |
| K041589 | Arthrex Fiberwire with SilkGAT · Traditional | 08/05/2004SE |
| K040907 | Arthrex Small Fragment Plates and ScrewsHRS · Traditional | 07/01/2004SE |
| K040381 | Hatric, 6&7MM, 9&10MM, 11&12MM, 14&15MM, Models AR-13000B-07, -10, -12, -15MQV · Traditional | 05/12/2004SE |
| K032245 | Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM…GAT · Traditional | 01/14/2004SESU |
| K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSHRS · Traditional | 11/18/2003SE |
| K032098 | Arthrex Bio-Compression Screw, Small, Arthrex Bio-Compression Screw, Large, Models…HWC · Traditional | 10/07/2003SE |
| K032187 | Anthrex Titanium Opening Wedge Osteotomy SystemHRS · Traditional | 09/22/2003SE |
| K031945 | Arthrex Trimit Screw, Model AR-4161BHWC · Traditional | 09/22/2003SE |
| K024291 | Arthrex Continuous Wave III Arthoscopy Pump, Model AR-6475HRX · Traditional | 03/20/2003SE |
| K030096 | Video Arthroscope, Models AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30…HRX · Traditional | 03/18/2003SE |
| K023119 | Bi-Cortical Bio Post and Washer, Model AR-1367BHTN · Traditional | 12/18/2002SE |
| K023986 | Arthrex Opes Electrodes and AccessoriesGEI · Traditional | 12/17/2002SE |
| K021434 | Arthrex Fiberwire in Usp SizesGAT · Traditional | 11/07/2002SE |
| K022234 | Arthrex Wrist Bio-Anchor, Model AR-1322BHWC · Traditional | 10/03/2002SE |
| K020345 | Arthrex Univers Fracture ProsthesisKWS · Traditional | 09/06/2002SE |
| K020043 | 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex Bio-Tenodesis Screw…HWC · Traditional | 04/02/2002SE |
| K014155 | Opening/Closing Wedge Ostetomy PlatesHRS · Traditional | 03/18/2002SE |
| K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201GAT · Traditional | 10/04/2001SE |
| K011495 | Arthrex Bio-Post and WasherMAI · Traditional | 08/01/2001SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0465-2023 Class II | Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S…The devices may be packaged with the wrong reamer size. | 11/02/2022Open, Classified |
| Z-1035-2022 Class II | K-Wire, 1.35 mm x 170 mmProducts do not meet length and diameter specifications. | 03/25/2022Terminated |
| Z-2107-2021 Class II | Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCCNot properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil… | 06/14/2021Open, Classified |
| Z-1380-2021 Class II | Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in…It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. | 03/11/2021Terminated |
| Z-1310-2021 Class II | Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and…The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color. | 02/24/2021Terminated |
| Z-2733-2020 Class II | Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product…Screws provided in packaging are 5mm shorter than intended | 06/24/2020Terminated |
| Z-0919-2020 Class II | Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger…There is a potential for blockage of the Hub Attachment Tube. | 12/17/2019Terminated |
| Z-1510-2020 Class II | Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used…Screws provided in the device package are 6 mm longer than intended. | 10/01/2019Terminated |
| Z-1206-2019 Class II | Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated…Devices may generate excessive heat during use. | 01/14/2019Terminated |
| Z-0724-2019 Class II | Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled…Potentially lead to anchor breakage during insertion, | 11/19/2018Open, Classified |
| Z-0442-2019 Class II | 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail…There is potential to break during use. | 09/13/2018Open, Classified |
| Z-0295-2019 Class II | Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery…The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around… | 08/27/2018Open, Classified |
| Z-0095-2018 Class II | iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC…Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 UFRA, size 1… | 10/03/2017Terminated |
| Z-2046-2017 Class II | Anthrex SpeedBridge Implant System with PEEK SwiveLock Self PunchingSome eyelets broke from SwiveLock Anchor on insertion. | 03/24/2017Terminated |
| Z-2045-2017 Class II | Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mmSome eyelets broke from SwiveLock Anchor on insertion. | 03/24/2017Terminated |
| Z-2044-2017 Class II | Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-PunchingSome eyelets broke from SwiveLock Anchor on insertion. | 03/24/2017Terminated |
| Z-2043-2017 Class II | Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-PunchingSome eyelets broke from SwiveLock Anchor on insertion. | 03/24/2017Terminated |
| Z-2042-2017 Class II | Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-PunchingSome eyelets broke from SwiveLock Anchor on insertion. | 03/24/2017Terminated |
| Z-2041-2017 Class II | Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-PunchingSome eyelets broke from SwiveLock Anchor on insertion. | 03/24/2017Terminated |
| Z-2918-2016 Class III | Arthrex Suture WasherThe device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in… | 08/12/2016Terminated |
| Z-1963-2016 Class II | BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. | 04/22/2016Terminated |
| Z-1962-2016 Class II | BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. | 04/22/2016Terminated |
| Z-1961-2016 Class II | BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. | 04/22/2016Terminated |
| Z-1960-2016 Class II | BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. | 04/22/2016Terminated |
| Z-1959-2016 Class II | BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. | 04/22/2016Terminated |
| Z-1958-2016 Class II | BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. | 04/22/2016Terminated |
| Z-1360-2016 Class II | Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a…Potential for a component contained in the Implant System to be non-sterile. | 01/11/2016Terminated |
| Z-1195-2016 Class II | Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog #…Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous… | 12/17/2015Terminated |