Panels › Orthopedic › Product code MBI · Class 2
Fastener, Fixation, Nondegradable, Soft Tissue
Regulation 888.3040
32510(k)s in 12 months (606 all time)
0recalls in 12 months (113 all time)
104recalls that name a 510(k)
Top companies in MBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Arthrex, Inc. | 52 | 1 |
| ArthroCare Corporation | 31 | 1 |
| Axya Medical, Inc. | 5 | 24 |
| Smith & Nephew | 23 | 5 |
| Riverpoint Medical | 23 | 1 |
| Parcus Medical | 23 | 0 |
| Innovasive Devices, Inc. | 22 | 0 |
| Biomet, Inc. | 10 | 10 |
| CONMED Corporation | 16 | 1 |
| Stryker | 10 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2020 | K192942 | ALLthread Titanium Suture Anchor Biomet, Inc. | MBI |
| Jan 16, 2020 | K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip Parcus Medical, LLC | MBI |
| Jan 2, 2020 | K193092 | TunneLoc Tibial Fixation Device Biomet, Inc. | MBI |
| Nov 26, 2019 | K191426 | FiberTak Button Arthrex, Inc. | MBI |
| Nov 22, 2019 | K192964 | Parcus Synd-EZ SS Parcus Medical, LLC | MBI |
| Oct 9, 2019 | K191783 | Parcus Synd-EZ Ti Parcus Medical, LLC | MBI |
| Oct 5, 2019 | K192428 | AFX Femoral Implant with Inserter Cayenne Medical | MBI |
| Sep 13, 2019 | K191459 | JuggerStitch Meniscal Repair Device Biomet, Inc. | MBI |
| Sep 13, 2019 | K190288 | Arthrex Tenodesis Button Arthrex, Inc. | MBI |
| Sep 12, 2019 | K191300 | MectaLock Ti Suture Anchor Medacta International S.A., CH | MBI |
| Aug 29, 2019 | K191319 | Dunamis Fixation Button System Dunamis, LLC | MBI |
| Jul 25, 2019 | K190774 | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant Medos International SARL, CH | MBI |
| Jul 17, 2019 | K191053 | Xtreme-Loop Xiros, Ltd., GB | MBI |
| Jul 3, 2019 | K191204 | Infinity Fixation System Conmed Corporation | MBI |
| Jul 3, 2019 | K190915 | OsteoFab Suture Anchors Oxford Performance Materials, Inc. | MBI |
| Jun 28, 2019 | K191483 | HEALIX ADVANCE Anchor with DYNA+TAPE Sutures Medos International SARL, CH | MBI |
| Jun 4, 2019 | K190892 | MectaScrew PEEK Interference Screw Medacta International S.A., CH | MBI |
| May 28, 2019 | K190474 | MectaLock PEEK Suture Anchor Medacta International S.A., CH | MBI |
| May 19, 2019 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyes T.A.G. Medical Products Corporation, Ltd., IL | MBI |
| Apr 24, 2019 | K190375 | Parcus ATLAS Parcus Medical, LLC | MBI |
| Apr 17, 2019 | K190728 | Arthrex SwiveLock Anchors Arthrex, Inc. | MBI |
| Mar 27, 2019 | K190446 | Responsive Arthroscopy Wedge Push-In Suture Anchors Responsive Arthroscopy, LLC | MBI |
| Mar 18, 2019 | K190333 | Paradigm All-Suture Anchor 1.8mm, White/Black #2 Conmed Corporation | MBI |
| Mar 1, 2019 | K183690 | Tenodesis Screw System Paragon 28, Inc. | MBI |
| Feb 26, 2019 | K182941 | HEALIX ADVANCE SP PEEK Anchor Medos International SARL, CH | MBI |
| Feb 21, 2019 | K183279 | HEALIX Ti ANCHOR with DYNACORD Medos International SARL, CH | MBI |
| Feb 7, 2019 | K183331 | Parcus GFS BTB Parcus Medical, LLC | MBI |
| Jan 21, 2019 | K182507 | Tigon Medical Tissue Anchors Tigon Medical | MBI |
| Jan 18, 2019 | K181076 | Responsive Arthroscopy Wedge Push-In Suture Anchors Responsive Arthroscopy, LLC | MBI |
| Jan 14, 2019 | K182898 | TenoTac Soft Tissue Fixation System Paragon 28, Inc. | MBI |
| Jan 9, 2019 | K181086 | Cortical Fixation Systems Cousin Biotech Sas, FR | MBI |
| Jan 8, 2019 | K182439 | TruShot with Y-Knot Shallow All-Suture Anchor Conmed Corporation | MBI |
| Jan 4, 2019 | K182621 | CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver Conmed Corporation | MBI |
| Jan 3, 2019 | K180951 | Responsive Arthroscopy Suture Anchor System Responsive Arthroscopy, LLC | MBI |
| Dec 28, 2018 | K182736 | OIC Suture Anchor System The Orthopaedic Implant Company | MBI |
| Dec 21, 2018 | K181120 | 2.8 mm/3.3 mm PopLok Suture Anchors Conmed Corporation | MBI |
| Dec 19, 2018 | K182446 | TruShot with Y-Knot All-Suture Anchor Conmed Corporation | MBI |
| Oct 19, 2018 | K182264 | ICONN Revolution Knotless Suture Anchor Iconn Orthopedics, LLC | MBI |
| Sep 21, 2018 | K181769 | Arthrex FiberTak Suture Anchor Arthrex, Inc. | MBI |
| Aug 30, 2018 | K181513 | Arthrex PushLock Tenodesis Anchor Arthrex, Inc. | MBI |
| Aug 9, 2018 | K181680 | ICONN Answer II Suture Anchor Iconn Orthopedics, LLC | MBI |
| Aug 9, 2018 | K180759 | SECULOK Suture Anchor U&I Corporation, KR | MBI |
| Aug 6, 2018 | K173845 | Arthrex SwiveLock Arthrex, Inc. | MBI |
| Jul 23, 2018 | K181083 | Stryker All-PEEK Knotless Anchor System Stryker | MBI |
| May 31, 2018 | K180464 | AEVUMED PHANTOM Suture Anchors Aevumed, Inc. | MBI |
| May 30, 2018 | K173269 | KATOR Suture Anchor Kator, LLC | MBI |
| Apr 4, 2018 | K173074 | ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor Stryker | MBI |
| Mar 21, 2018 | K180274 | Ventix Link Knotless Anchor with Inserter Cayenne Medical, Inc. | MBI |
| Feb 12, 2018 | K180118 | Arthrex NanoSuture Anchor Arthrex, Inc. | MBI |
| Jan 5, 2018 | K173278 | ToggleLoc System Biomet, Inc. | MBI |
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