Panels › Orthopedic › Product code MAI · Class 2
Fastener, Fixation, Biodegradable, Soft Tissue
Regulation 888.3030
5510(k)s in 12 months (221 all time)
9recalls in 12 months (97 all time)
96recalls that name a 510(k)
Top companies in MAI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2020 | K193503 | Arthrex SwiveLock Suture Anchor Arthrex, Inc. | MAI |
| Dec 12, 2019 | K193157 | Arthrex 3.9mm Corkscrew Suture Anchor Arthrex, Inc. | MAI |
| Nov 2, 2019 | K192824 | Parcus Knotless AP Suture Anchors Parcus Medical, LLC | MAI |
| Oct 19, 2019 | K192532 | Arthrex SwiveLock Anchor Arthrex, Inc. | MAI |
| Oct 17, 2019 | K192441 | Arthrex SwiveLock Anchors Arthrex, Inc. | MAI |
| Aug 22, 2019 | K191242 | HEALIX ADVANCE SP BIOCOMPOSITE Anchor Medos International SARL, CH | MAI |
| Jun 11, 2019 | K191226 | Arthrex SwiveLock Suture Anchor Arthrex, Inc. | MAI |
| Mar 15, 2019 | K183501 | Parcus Twist AP Suture Anchors Parcus Medical, LLC | MAI |
| Mar 11, 2019 | K183236 | Rotium Bioresorbable Wick Nanofiber Solutions, LLC | MAI |
| Feb 14, 2019 | K183506 | HEALIX ADVANCE Anchor with DYNACORD Suture Medos International SARL, CH | MAI |
| Dec 14, 2018 | K180768 | Arthrex SwiveLock Anchors Arthrex, Inc. | MAI |
| Sep 28, 2018 | K181746 | MICRORAPTOR Knotless Suture Anchor Smith and Nephew, Inc. | MAI |
| Aug 3, 2018 | K181809 | GRYPHON® Anchors with DYNACORD Suture Medos International SARL, CH | MAI |
| Jul 25, 2018 | K180960 | FIXIT / ComposiTCP Threaded Anchor System S.B.M. Sas Sciences For Bio Materials, FR | MAI |
| Jul 19, 2018 | K180763 | CuffLink Implant System Biocomposite Conmed Corporation | MAI |
| Jun 22, 2018 | K180594 | Knotless SutureTak Anchors Arthrex, Inc. | MAI |
| May 30, 2018 | K180361 | MICRORAPTOR REGENESORB Suture Anchor Smith and Nephew, Inc. | MAI |
| May 22, 2018 | K180662 | Arthrex FastThread Interference Screw Arthrex, Inc. | MAI |
| May 10, 2018 | K180101 | HEALIX ADVANCE KNOTLESS BR Anchor Medos International SARL, CH | MAI |
| Apr 11, 2018 | K173859 | HEALIX ADVANCE Anchor with DYNACORD Suture Medos International SARL, CH | MAI |
| Mar 1, 2018 | K173788 | Arthrex Corkscrew FT Arthrex, Inc. | MAI |
| Jan 19, 2018 | K171228 | Fiji Anchor Sportwelding GmbH, CH | MAI |
| Jan 16, 2018 | K173240 | Arthrex PushLock Arthrex, Inc. | MAI |
| Nov 30, 2017 | K170868 | FIXIT Threaded Anchor System S.B.M Sas Science For Bio Materials, FR | MAI |
| Nov 27, 2017 | K171114 | HEALIX ADVANCE KNOTLESS Anchor Medos International SARL, CH | MAI |
| Aug 29, 2017 | K171592 | CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver Conmed Corporation | MAI |
| Aug 24, 2017 | K171299 | Fixone Biocomposite Anchor Aju Pharm Co., Ltd., KR | MAI |
| May 18, 2017 | K170639 | HEALIX ADVANCE Anchor with PERMATAPE Suture Medos International SARL, CH | MAI |
| May 5, 2017 | K163672 | Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor Nanova Biomaterials, Inc. | MAI |
| May 4, 2017 | K171141 | Arthrex SwiveLock Anchors Arthrex, Inc. | MAI |
| Mar 17, 2017 | K170501 | CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver Conmed Corporation | MAI |
| Mar 13, 2017 | K162429 | ZipE Knotless Tissue Repair and Attachment Devices Ziptek, LLC | MAI |
| Nov 3, 2016 | K161174 | Nanova Interference Screw Nanova Biomaterials, Inc. | MAI |
| Jul 19, 2016 | K160804 | INTRAFIX(TM) Advance Tibial Fastener System Medos International SARL, CH | MAI |
| Mar 24, 2016 | K151342 | Arthrex SwiveLock Anchors Arthrex, Inc. | MAI |
| Oct 6, 2015 | K150209 | Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Depuy Mitek, A Johnson and Johnson Company | MAI |
| Jul 28, 2015 | K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Sutur Smith & Nephew, Inc. | MAI |
| May 21, 2015 | K143660 | Milagro / Milagro Advance Interference Screw Depuy Mitek, A Johnson & Johnson Company | MAI |
| Feb 4, 2015 | K143172 | ACL SMART System Smith & Nephew, Inc. | MAI |
| Jan 13, 2015 | K142948 | BIOSURE REGENESORB interference Screw Smith & Nephew, Inc. | MAI |
| Dec 18, 2014 | K140855 | ARTHREX SUTURETAK SUTURE ANCHORS Arthrex, Inc. | MAI |
| Jul 8, 2014 | K140643 | GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY Depuy Mitek, A Johnson and Johnson Company | MAI |
| Jun 10, 2014 | K141259 | GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK Depuy Mitek, A Johnson & Johnson Company | MAI |
| Feb 4, 2014 | K133794 | 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 Depuy Mitek, A Johnson & Johnson Company | MAI |
| Nov 5, 2013 | K132241 | GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T Depuy Mitek, A Johnson & Johnson Company | MAI |
| Aug 28, 2013 | K130716 | BIORETEC ACTIVASCREW INTERFERENCE Bioretec, Ltd., FI | MAI |
| Jul 25, 2013 | K131974 | HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) Depuy Mitek, A Johnson & Johnson Company | MAI |
| May 24, 2013 | K130917 | HEALIX ADVANCE KNOTLESS BR ANCHOR Depuy Mitek, A Johnson & Johnson Company | MAI |
| May 13, 2013 | K122635 | TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR Tornier, Inc. | MAI |
| Apr 11, 2013 | K123393 | HEALICOIL SUTURE ANCHOR WITH REGENESORB Smith & Nephew, Inc. | MAI |
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