Fastener, Fixation, Biodegradable, Soft Tissue
FDA product code MAI · Class II (moderate risk) · 21 CFR 888.3030 · Orthopedic
221510(k) clearances
0PMA approvals
94recalls
Implantimplanted device
Manufacturers
- Arthrex, Inc. 46
- Depuy Mitek, A Johnson & Johnson Company 18
- Bionx Implants, Inc. 11
- Linvatec Corp. 11
- Smith & Nephew, Inc. 10
- Medos International SARL 8
- OSSIO , Ltd. 5
- Conmed Corporation 5
- Aju Pharm Co., Ltd. 5
- Acuitive Technologies, Inc. 5
- Stryker Endoscopy 4
- Osteonic Co., Ltd. 4
- Innovasive Devices, Inc. 4
- Li Medical Technologies, Inc. 4
- Nanofiber Solutions, LLC 4
- Mitek Products 3
- Biomet, Inc. 3
- Axya Medical 3
- Bioscience, Inc. 3
- Bonutti Research, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | Arthrex, Inc. | 08/07/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | Arthrex, Inc. | 05/28/2026SE |
| K260294 | SF Push-in AnchorMAI · Traditional | Surgical Fusion Technologies GmbH | 03/27/2026SE |
| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | OSSIO , Ltd. | 02/24/2026SE |
| K251680 | Biosteon® ScrewMAI · Traditional | Biocomposites, Ltd. | 02/17/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | Conmed Corporation | 10/15/2025SE |
| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | OSSIO , Ltd. | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | OSSIO , Ltd. | 05/27/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | Stryker Endoscopy | 05/23/2025SE |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | Stryker Endoscopy | 05/21/2025SE |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mmMAI · Traditional | OSSIO , Ltd. | 04/03/2025SE |
| K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorMAI · Special | Arthrex, Inc. | 03/14/2025SE |
| K243790 | GRYPHON X Anchor; HEALIX TRANSTEND AnchorMAI · Traditional | Depuy Mitek | 02/05/2025SE |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAI · Special | Osteonic Co., Ltd. | 12/03/2024SE |
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsMAI · Special | Depuy Mitek | 09/11/2024SE |
| K241912 | BiochargeMAI · Special | Nanofiber Solutions, LLC | 07/29/2024SE |
| K233971 | Arthrex AlloSync PushLock Suture AnchorMAI · Traditional | Arthrex, Inc. | 06/04/2024SE |
| K240288 | SF Push- in AnchorMAI · Traditional | Surgical Fusion Technologies GmbH | 04/01/2024SE |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewMAI · Special | Depuy Mitek | 03/15/2024SE |
| K240090 | Argo Knotless GENESYS AnchorMAI · Traditional | Conmed Corporation | 03/05/2024SE |
| K232513 | X-Twist Biocomposite Suture AnchorMAI · Special | Parcus Medical | 09/18/2023SE |
| K231787 | ecoFIX®MAI · Special | Science & Bio Materials (S.B.M.) Sas | 07/26/2023SE |
| K231641 | Rotium Bioresorbable WickMAI · Special | Nanofiber Solutions, LLC | 07/05/2023SE |
| K230892 | Fixone Biocomposite AnchorMAI · Special | Aju Pharm Co., Ltd. | 06/09/2023SE |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)MAI · Special | Osteonic Co., Ltd. | 05/31/2023SE |
| K230394 | Euroscrew NG; Euroscrew TCP NGMAI · Traditional | Teknimed | 05/12/2023SE |
| K230435 | Arthrex 3.9 mm SwiveLock AnchorMAI · Special | Arthrex, Inc. | 03/17/2023SE |
| K221468 | Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device…MAI · Traditional | Acuitive Technologies, Inc. | 02/14/2023SE |
| K220833 | Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock…MAI · Traditional | Acuitive Technologies, Inc. | 11/04/2022SE |
| K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIMAI · Traditional | Arthrex, Inc. | 10/05/2022SE |
| K222263 | Arthrex Self Punching SwiveLock Suture AnchorsMAI · Special | Arthrex, Inc. | 08/26/2022SE |
| K221099 | Arthrex Self-Punching PushLock Suture AnchorMAI · Special | Arthrex, Inc. | 05/13/2022SE |
| K213958 | Bioabsorbable AnchorMAI · Traditional | Embody, Inc. | 04/08/2022SE |
| K213415 | OSSIOfiber Suture AnchorMAI · Traditional | OSSIO , Ltd. | 03/28/2022SE |
| K203523 | Fixone hybrid knotless anchorMAI · Traditional | Aju Pharm Co., Ltd. | 12/25/2021SE |
| K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…MAI · Traditional | B-One Ortho, Corp. | 11/04/2021SE |
| K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)MAI · Traditional | Osteonic Co., Ltd. | 08/27/2021SE |
| K202806 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAI · Traditional | Osteonic Co., Ltd. | 06/17/2021SE |
| K203495 | Arthrex SwiveLock AnchorMAI · Traditional | Arthrex, Inc. | 04/19/2021SE |
| K210239 | CITRESPLINE and CITRELOCK ACL ImplantsMAI · Special | Acuitive Technologies, Inc. | 02/24/2021SE |
| K203493 | MectaLock ExtensionMAI · Traditional | Medacta International S.A. | 02/22/2021SE |
| K203334 | The Citrefix Knotless Suture AnchorMAI · Traditional | Acuitive Technologies, Inc. | 02/05/2021SE |
| K202535 | Arthrex FastThread Interference ScrewMAI · Special | Arthrex, Inc. | 11/18/2020SE |
| K200725 | Citregen Tendon Interference Screw and CitrelockMAI · Traditional | Acuitive Technologies | 10/07/2020SE |
| K201749 | Arthrex SwiveLock AnchorMAI · Traditional | Arthrex, Inc. | 08/21/2020SE |
| K201786 | Arthrex Mini Hip PushLockMAI · Special | Arthrex, Inc. | 07/30/2020SE |
| K201414 | Rotium Bioresorbable WickMAI · Special | Nanofiber Solutions, LLC | 06/25/2020SE |
| K193558 | HEALICOIL Knotless Suture AnchorsMAI · Traditional | Smith & Nephew, Inc. | 03/18/2020SE |
| K192484 | Fixone Biocomposite AnchorMAI · Special | Aju Pharm Co., Ltd. | 03/11/2020SE |
| K192032 | Fixone Biocomposite Small AnchorMAI · Traditional | Aju Pharm Co., Ltd. | 03/03/2020SE |
| K193503 | Arthrex SwiveLock Suture AnchorMAI · Special | Arthrex, Inc. | 01/15/2020SE |
| K193157 | Arthrex 3.9mm Corkscrew Suture AnchorMAI · Special | Arthrex, Inc. | 12/12/2019SE |
| K192824 | Parcus Knotless AP Suture AnchorsMAI · Special | Parcus Medical, LLC | 11/02/2019SE |
| K192532 | Arthrex SwiveLock AnchorMAI · Special | Arthrex, Inc. | 10/19/2019SE |
| K192441 | Arthrex SwiveLock AnchorsMAI · Special | Arthrex, Inc. | 10/17/2019SE |
| K191242 | HEALIX ADVANCE SP BIOCOMPOSITE AnchorMAI · Traditional | Medos International SARL | 08/22/2019SE |
| K191226 | Arthrex SwiveLock Suture AnchorMAI · Special | Arthrex, Inc. | 06/11/2019SE |
| K183501 | Parcus Twist AP Suture AnchorsMAI · Traditional | Parcus Medical, LLC | 03/15/2019SE |
| K183236 | Rotium Bioresorbable WickMAI · Traditional | Nanofiber Solutions, LLC | 03/11/2019SE |
| K183506 | HEALIX ADVANCE Anchor with DYNACORD SutureMAI · Traditional | Medos International SARL | 02/14/2019SE |
| K180768 | Arthrex SwiveLock AnchorsMAI · Traditional | Arthrex, Inc. | 12/14/2018SE |
| K181746 | MICRORAPTOR Knotless Suture AnchorMAI · Traditional | Smith and Nephew, Inc. | 09/28/2018SE |
| K181809 | GRYPHON® Anchors with DYNACORD SutureMAI · Special | Medos International SARL | 08/03/2018SE |
| K180960 | FIXIT / ComposiTCP Threaded Anchor SystemMAI · Special | S.B.M. Sas Sciences For Bio Materials | 07/25/2018SE |
| K180763 | CuffLink Implant System BiocompositeMAI · Traditional | Conmed Corporation | 07/19/2018SE |
| K180594 | Knotless SutureTak AnchorsMAI · Traditional | Arthrex, Inc. | 06/22/2018SE |
| K180361 | MICRORAPTOR REGENESORB Suture AnchorMAI · Traditional | Smith and Nephew, Inc. | 05/30/2018SE |
| K180662 | Arthrex FastThread Interference ScrewMAI · Special | Arthrex, Inc. | 05/22/2018SE |
| K180101 | HEALIX ADVANCE KNOTLESS BR AnchorMAI · Traditional | Medos International SARL | 05/10/2018SE |
| K173859 | HEALIX ADVANCE Anchor with DYNACORD SutureMAI · Traditional | Medos International SARL | 04/11/2018SE |
| K173788 | Arthrex Corkscrew FTMAI · Special | Arthrex, Inc. | 03/01/2018SE |
| K171228 | Fiji AnchorMAI · Traditional | Sportwelding GmbH | 01/19/2018SE |
| K173240 | Arthrex PushLockMAI · Traditional | Arthrex, Inc. | 01/16/2018SE |
| K170868 | FIXIT Threaded Anchor SystemMAI · Traditional | S.B.M Sas Science For Bio Materials | 11/30/2017SE |
| K171114 | HEALIX ADVANCE KNOTLESS AnchorMAI · Traditional | Medos International SARL | 11/27/2017SE |
| K171592 | CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverMAI · Traditional | Conmed Corporation | 08/29/2017SE |
| K171299 | Fixone Biocomposite AnchorMAI · Traditional | Aju Pharm Co., Ltd. | 08/24/2017SE |
| K170639 | HEALIX ADVANCE Anchor with PERMATAPE SutureMAI · Traditional | Medos International SARL | 05/18/2017SE |
| K163672 | Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorMAI · Traditional | Nanova Biomaterials, Inc. | 05/05/2017SE |
| K171141 | Arthrex SwiveLock AnchorsMAI · Special | Arthrex, Inc. | 05/04/2017SE |
| K170501 | CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverMAI · Special | Conmed Corporation | 03/17/2017SE |
| K162429 | ZipE Knotless Tissue Repair and Attachment DevicesMAI · Traditional | Ziptek, LLC | 03/13/2017SE |
| K161174 | Nanova Interference ScrewMAI · Traditional | Nanova Biomaterials, Inc. | 11/03/2016SE |
| K160804 | INTRAFIX(TM) Advance Tibial Fastener SystemMAI · Traditional | Medos International SARL | 07/19/2016SE |
| K151342 | Arthrex SwiveLock AnchorsMAI · Traditional | Arthrex, Inc. | 03/24/2016SE |
| K150209 | Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor…MAI · Traditional | Depuy Mitek, A Johnson and Johnson Company | 10/06/2015SE |
| K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…MAI · Traditional | Smith & Nephew, Inc. | 07/28/2015SE |
| K143660 | Milagro / Milagro Advance Interference ScrewMAI · Traditional | Depuy Mitek, A Johnson & Johnson Company | 05/21/2015SE |
| K143172 | ACL SMART SystemMAI · Traditional | Smith & Nephew, Inc. | 02/04/2015SE |
| K142948 | BIOSURE REGENESORB interference ScrewMAI · Traditional | Smith & Nephew, Inc. | 01/13/2015SE |
| K140855 | Arthrex Suturetak Suture AnchorsMAI · Traditional | Arthrex, Inc. | 12/18/2014SE |
| K140643 | Gryphon BR Anchor W/Proknot Technology,Gryphon PEEK Anchor W/ Proknot TechnologyMAI · Traditional | Depuy Mitek, A Johnson and Johnson Company | 07/08/2014SE |
| K141259 | Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon PEEK…MAI · Special | Depuy Mitek, A Johnson & Johnson Company | 06/10/2014SE |
| K133794 | 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…MAI · Traditional | Depuy Mitek, A Johnson & Johnson Company | 02/04/2014SE |
| K132241 | Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…MAI · Traditional | Depuy Mitek, A Johnson & Johnson Company | 11/05/2013SE |
| K130716 | Bioretec Activascrew InterferenceMAI · Traditional | Bioretec, Ltd. | 08/28/2013SE |
| K131974 | Healix Advance Knotless BR Anchor (6.5MM)MAI · Special | Depuy Mitek, A Johnson & Johnson Company | 07/25/2013SE |
| K130917 | Healix Advance Knotless BR AnchorMAI · Traditional | Depuy Mitek, A Johnson & Johnson Company | 05/24/2013SE |
| K122635 | Tornier Insite FT Biocomposite Suture AnchorMAI · Traditional | Tornier, Inc. | 05/13/2013SE |
| K123393 | Healicoil Suture Anchor with RegenesorbMAI · Traditional | Smith & Nephew, Inc. | 04/11/2013SE |
| K122869 | Milagro Interference ScrewsMAI · Traditional | Depuy Mitek, A Johnson & Johnson Company | 12/13/2012SE |
| K122228 | Ligafix Interference ScrewMAI · Special | Sbm Sciences For Bio Materials | 10/03/2012SE |
| K121890 | Genesys Pressft Suture AnchorMAI · Special | Linvatec Corporation D/B/A Conmed Linvatec | 08/22/2012SE |
| K120589 | Milagro Interference ScrewsMAI · Traditional | Depuy Mitek, A Johnson & Johnson Company | 04/24/2012SE |
| K120540 | BioboltMAI · Special | Arthrex, Inc. | 03/20/2012SE |
| K120078 | Healix Advance BR AnchorMAI · Traditional | Depuy Mitek Inc., Johnson and Johnson Company | 02/29/2012SE |
| K113534 | Healix Knotless AnchorMAI · Special | Depuy Mitek, A Johnson & Johnson Company | 12/20/2011SE |
| K112040 | Arthrex Biocomposite TransfixMAI · Special | Arthrex, Inc. | 12/15/2011SE |
| K112249 | Healix Knotless(Tm) AnchorMAI · Traditional | Depuy Mitek, A Johnson & Johnson Company | 10/25/2011SE |
| K103831 | Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809MAI · Traditional | Depuy Mitek, A Johnson & Johnson Company | 07/21/2011SE |
| K110660 | Arthrex Biocomposite SuturetakMAI · Special | Arthrex, Inc. | 03/31/2011SE |
| K103309 | Osteoraptor Curved 2.3 Suture AnchorsMAI · Traditional | Smith & Nephew Endoscopy, Inc. | 02/03/2011SE |
| K101459 | Osteoraptor II Suture Anchor or to Be Determined Model: 72202764 72202765 72202766…MAI · Traditional | Smith & Nephew, Inc. | 01/27/2011SE |
| K101823 | Arthrex Swivelock AnchorsMAI · Traditional | Arthrex, Inc. | 01/07/2011SE |
| K102982 | Endobutton DirectMAI · Traditional | Smith & Nephew Inc., Endoscopy Division | 01/05/2011SE |
| K101679 | Arthrex Pushlock AnchorsMAI · Traditional | Arthrex, Inc. | 10/22/2010SE |
| K101100 | Crossft Oc Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503MAI · Traditional | Conmed Linvatec | 08/26/2010SE |
| K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…MAI · Traditional | Depuy Mitek, A Johnson & Johnson Company | 04/30/2010SE |
| K093844 | Smith & Nephew Twinfix Ultra Ha Suture AnchorMAI · Traditional | Smith & Nephew, Inc. | 04/01/2010SE |
| K092898 | Conmed Linvatec Presto Preloaded with One or Two #2 Hi-Fi SuturesMAI · Special | Conmed Linvatec | 10/19/2009SE |
| K091844 | Arthrex Bio-Composite Suturetak AnchorsMAI · Special | Arthrex, Inc. | 08/28/2009SE |
| K091041 | Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST…MAI · Traditional | Depuy Mitek, A Johnson & Johnson Company | 08/07/2009SE |
| K090835 | Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRMAI · Traditional | Linvatec Corp. | 06/22/2009SE |
| K090186 | Conmed Linvatec Paladin, Preloaded with Two #2 Hi-Fi SuturesMAI · Special | Linvatec Corp. | 04/10/2009SE |
| K090669 | Rigidfix Biocryl Cross Pin KitsMAI · Special | Depuy Mitek, A Johnson & Johnson Company | 04/03/2009SE |
| K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814MAI · Special | Depuy Mitek, A Johnson & Johnson Company | 03/11/2009SE |
| K083268 | Tornier, Inc., Insite Suture AnchorsMAI · Traditional | Tornier, Inc. | 02/12/2009SE |
| K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…MAI · Traditional | Arthrex, Inc. | 01/23/2009SE |
| K082999 | Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral DartMAI · Traditional | Arthrex, Inc. | 12/30/2008SE |
| K073412 | Gryphon BR and Healix BR AnchorsMAI · Traditional | Depuy Mitek, A Johnson & Johnson Company | 01/17/2008SE |
| K071456 | Arthrex Prostop Plus Arthroereisis Subtalar ImplantMAI · Traditional | Arthrex, Inc. | 01/17/2008SE |
| K071176 | Modification to: Arthrex Interference ScrewMAI · Traditional | Arthrex, Inc. | 08/03/2007SE |
| K070925 | Modification to: Bioknotless BR Anchor / Lupine BR AnchorMAI · Special | Depuy Mitek, A Johnson & Johnson Company | 05/02/2007SE |
| K070178 | Aesculap Resorbable Pin, Model FR735MAI · Traditional | Aesculap Implant System, Inc. | 04/30/2007SE |
| K053492 | BioductMAI · Traditional | Bioduct, LLC | 04/12/2007SE |
| K063497 | Modification to Scandius Tritis Absorbable Tibial Reconstruction SystemMAI · Special | Scandius Biomedical, Inc. | 12/19/2006SE |
| K062466 | Arthrex Interference ScrewMAI · Traditional | Arthrex, Inc. | 11/29/2006SE |
| K062782 | Inion Anchron Plus Biodegradable Anchor System, Model ANC-6001MAI · Special | Inion OY | 11/09/2006SE |
| K060522 | Scandius Tritis Absorbable Tibial Reconstruction SystemMAI · Traditional | Scandius Biomedical, Inc. | 04/11/2006SE |
| K052799 | Multitak 6.0 MM Absorbable Anchor SystemMAI · Traditional | Bonutti Research, Inc. | 12/16/2005SE |
| K051983 | Model 3000 Axyaloop Bio-Absorbable Bone AnchorMAI · Special | Axya Medical, Inc. | 08/05/2005SE |
| K051362 | Inion Anchron Biodegradable Anchor System, Model ANC-6000MAI · Traditional | Inion OY | 08/04/2005SE |
| K051219 | PushlockMAI · Special | Arthrex, Inc. | 06/29/2005SE |
| K051250 | Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorMAI · Special | Axya Medical, Inc. | 06/09/2005SE |
| K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…MAI · Special | Linvatec Biomaterials, Ltd. | 11/19/2004SE |
| K041698 | Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorMAI · Traditional | Axya Medical, Inc. | 10/05/2004SE |
| K041128 | Suture ArrowMAI · Traditional | Linvatec Corp. | 07/29/2004SE |
| K041307 | Modification to Stryker Xcel Anchor SystemMAI · Special | Stryker Endoscopy | 06/14/2004SE |
| K041305 | Stryker Biozip Suture Anchor SystemMAI · Special | Stryker Endoscopy | 06/14/2004SE |
| K040827 | Panalok Loop AnchorMAI · Special | Depuy Mitek, A Johnson & Johnson Company | 04/30/2004SE |
| K032197 | Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212MAI · Special | Smith & Nephew, Inc. | 08/08/2003SE |
| K031981 | 2.4 Smartnail, Models 532416, 532425, 532435, 532445MAI · Special | Linvatec Biomaterials, Ltd. | 07/25/2003SE |
| K031519 | Cufflok AnchorMAI · Special | Mitek Worldwide | 06/06/2003SE |
| K011985 | Smith & Nephew Phoenix 5.0 Allograft Anchor KitMAI · Traditional | Smith & Nephew, Inc. | 11/02/2001SE |
| K012465 | Multitak Splinter 3.0 MM Resorbable AnchorMAI · Traditional | Bonutti Research, Inc. | 10/29/2001SE |
| K013057 | Biocuff,C, Models 236018, 236028, 236036MAI · Special | Bionx Implants, Inc. | 10/12/2001SE |
| K012334 | Contour Meniscus Arrow, Models 541110, 541113, and 541116MAI · Special | Bionx Implants, Inc. | 09/19/2001SE |
| K011495 | Arthrex Bio-Post and WasherMAI · Traditional | Arthrex, Inc. | 08/01/2001SE |
| K011299 | Smith and Nephew 5.00MM Absorbable Polymer AnchorMAI · Traditional | Smith & Nephew, Inc. | 06/27/2001SE |
| K003984 | Super Revo Suture AnchorMAI · Traditional | Linvatec Corp. | 03/19/2001SE |
| K002406 | Mitek 2GII Meniscal Repair SystemMAI · Traditional | Mitek Products | 02/15/2001SE |
| K003743 | Synthes Modified Bioresorbable Suture Anchor SystemMAI · Traditional | Synthes (Usa) | 02/09/2001SE |
| K003970 | Contour Labral Nail, Model 533520AMAI · Special | Bionx Implants, Inc. | 01/12/2001SE |
| K003273 | Lactosorb Screw AnchorMAI · Traditional | Biomet, Inc. | 01/11/2001SE |
| K003227 | Bio-Absorbable Corkscrew Model AR-1920BMAI · Traditional | Arthrex, Inc. | 01/08/2001SE |
| K003076 | Mitek CufftackMAI · Special | Mitek Products | 10/27/2000SE |
| K002413 | Ultrasorb Suture AnchorMAI · Traditional | Li Medical Technologies, Inc. | 09/19/2000SE |
| K002020 | Lactosorb Meniscal ScrewMAI · Traditional | Biomet Manufacturing, Inc. | 08/25/2000SE |
| K994161 | Synthes Bioresorbable Suture AnchorMAI · Traditional | Synthes (Usa) | 07/28/2000SE |
| K001378 | Biocuff, Models 225718, 225728, 225736, 235718, 235728, 235736MAI · Traditional | Bionx Implants, Inc. | 07/28/2000SE |
| K000506 | Bio-Fastak Suture Anchor, Model AR-1324BMAI · Traditional | Arthrex, Inc. | 05/01/2000SE |
| K000616 | Smartwedge Acl, Models 430623, 430628, 430723, 430728, 430823, 430828MAI · Special | Bionx Implants, Ltd. | 03/23/2000SE |
| K990340 | Arthrex Pla Tissuetak, Model # AR-1940 BuMAI · Traditional | Arthrex, Inc. | 01/28/2000SE |
| K990987 | Bio-Absorbable Corkscrew, Model AR-1920BMAI · Traditional | Arthrex, Inc. | 01/13/2000SE |
| K994269 | Titan RC TackMAI · Special | Innovasive Devices, Inc. | 01/10/2000SE |
| K993115 | Multitak SSMAI · Traditional | Bonutti Research, Inc. | 12/17/1999SE |
| K993339 | Endopearl with ThreaderMAI · Traditional | Linvatec Corp. | 12/10/1999SE |
| K993074 | Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525MAI · Traditional | Bionx Implants, Ltd. | 12/10/1999SE |
| K993073 | Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…MAI · Traditional | Bionx Implants, Ltd. | 12/06/1999SE |
| K993061 | Stryker Leibinger Resorbable Fixation SystemMAI · Traditional | Stryker Instruments | 11/19/1999SE |
| K993453 | Meniscus Arrow, Models 531110, 531113, 531116MAI · Special | Bionx Implants, Ltd. | 11/09/1999SE |
| K993373 | Rotorblade Suture AnchorMAI · Special | Li Medical Technologies, Inc. | 10/27/1999SE |
| K992938 | Rotorblade Suture AnchorMAI · Special | Li Medical Technologies, Inc. | 09/23/1999SE |
| K992567 | Anatomical Bankart Tack, Model 523520AMAI · Special | Bionx Implants, Ltd. | 08/27/1999SE |
| K983577 | Arthrex Meniscal Dart SystemMAI · Traditional | Arthrex, Inc. | 08/13/1999SE |
| K991715 | Biostinger-V Bioabsorbable Meniscal Repair DeviceMAI · Traditional | Linvatec Corp. | 08/06/1999SE |
| K991009 | RC ButtressMAI · Traditional | Biomet, Inc. | 06/23/1999SE |
| K984171 | EndopearlMAI · Traditional | Linvatec Corp. | 04/29/1999SE |
| K983435 | RotorbladeMAI · Abbreviated | Li Medical Technologies, Inc. | 04/29/1999SE |
| K990999 | Modification of: Ebi Spinelink SystemMAI · Special | Electro-Biology, Inc. | 04/14/1999SE |
| K990361 | Headed Bio-Absorbable Corkscrew Model #AR-1921BUMAI · Traditional | Arthrex, Inc. | 04/14/1999SE |
| K983843 | Bio-Button 6.5MM, Bio-Button 8MM, Model #'S AR-2236B & AR-2238BMAI · Traditional | Arthrex, Inc. | 03/12/1999SE |
| K984490 | Sutureless AnchorMAI · Traditional | Innovasive Devices, Inc. | 03/01/1999SE |
| K982095 | Lactosorb Meniscal Repair DeviceMAI · Traditional | Biomet, Inc. | 01/27/1999SE |
| K983186 | Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorMAI · Traditional | Linvatec Corp. | 10/21/1998SE |
| K982900 | Phantom Softhread Soft Tissue Interference ScrewMAI · Special | Depuy, Inc. | 08/31/1998SE |
| K981340 | Innovasive Devices Meniscal Dart Repair SystemMAI · Traditional | Innovasive Devices, Inc. | 06/22/1998SE |
| K972783 | Biofix Biodegradable Threaded Suture AnchorMAI · Traditional | Bionx Implants, Inc. | 04/14/1998SE |
| K974876 | Bionx Distal Radius ScrewMAI · Traditional | Bionx Implants, Inc. | 03/20/1998SE |
| K973381 | Bioroc Ez Suture Bone FastenerMAI · Traditional | Innovasive Devices, Inc. | 02/18/1998SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3018-2026 Class II | CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B…Suture anchor may contain incorrect patient implant card which may result in incorrect device identification… | ConMed Corporation | 07/14/2026Open, Classified |
| Z-1173-2026 Class II | AlternatiV+ Screw-In AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | Aju Pharm Co., Ltd. | 12/17/2025Open, Classified |
| Z-1172-2026 Class II | AlternatiV+ Max Knotless AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | Aju Pharm Co., Ltd. | 12/17/2025Open, Classified |
| Z-1171-2026 Class II | Genesis Push-In Suture AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | Aju Pharm Co., Ltd. | 12/17/2025Open, Classified |
| Z-1170-2026 Class II | Genesis Knotless AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | Aju Pharm Co., Ltd. | 12/17/2025Open, Classified |
| Z-1169-2026 Class II | Genesis Dual Thread Screw-In AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | Aju Pharm Co., Ltd. | 12/17/2025Open, Classified |
| Z-1168-2026 Class II | Genesis Screw-In AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | Aju Pharm Co., Ltd. | 12/17/2025Open, Classified |
| Z-1167-2026 Class II | Fixone Biocomposite AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | Aju Pharm Co., Ltd. | 12/17/2025Open, Classified |
| Z-1166-2026 Class II | Fixone Hybrid AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | Aju Pharm Co., Ltd. | 12/17/2025Open, Classified |
| Z-1681-2023 Class II | DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation…IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter… | DePuy Mitek, Inc., a Johnson & Johnson Co. | 04/13/2023Open, Classified |
| Z-1680-2023 Class II | DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in…IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter… | DePuy Mitek, Inc., a Johnson & Johnson Co. | 04/13/2023Open, Classified |
| Z-1679-2023 Class II | DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in…IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter… | DePuy Mitek, Inc., a Johnson & Johnson Co. | 04/13/2023Open, Classified |
| Z-1678-2023 Class II | DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone…IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter… | DePuy Mitek, Inc., a Johnson & Johnson Co. | 04/13/2023Open, Classified |
| Z-1677-2023 Class II | DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone…IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter… | DePuy Mitek, Inc., a Johnson & Johnson Co. | 04/13/2023Open, Classified |
| 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… | Arthrex, Inc. | 06/14/2021Open, Classified |
| Z-1510-2021 Class II | CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference…Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw | Smith & Nephew, Inc. | 04/08/2021Terminated |
| Z-0175-2021 Class II | MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0174-2021 Class II | MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0173-2021 Class II | HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0172-2021 Class II | HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0171-2021 Class II | HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0170-2021 Class II | HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0169-2021 Class II | HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0168-2021 Class II | HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0167-2021 Class II | HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0166-2021 Class II | OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0165-2021 Class II | OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0164-2021 Class II | TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0163-2021 Class II | TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0162-2021 Class II | TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0161-2021 Class II | TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0160-2021 Class II | TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0159-2021 Class II | TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0158-2021 Class II | TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0157-2021 Class II | TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0156-2021 Class II | TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0155-2021 Class II | TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0154-2021 Class II | OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0153-2021 Class II | OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0152-2021 Class II | OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0151-2021 Class II | OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0150-2021 Class II | OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0149-2021 Class II | OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0148-2021 Class II | OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0147-2021 Class II | RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0146-2021 Class II | BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0145-2021 Class II | ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0144-2021 Class II | ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0143-2021 Class II | ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |
| Z-0142-2021 Class II | TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | Smith & Nephew, Inc. | 09/09/2020Open, Classified |