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 |
|---|---|---|---|
| Nov 29, 2017 | K172491 | ICONN Square 2.5MM Suture Anchor Iconn Orthopedics, LLC | MBI |
| Nov 20, 2017 | K172921 | Stryker Self-Punching ICONIX Stryker | MBI |
| Oct 23, 2017 | K171640 | M-ARS ACL: Anatomic Ribbon Surgery System Medacta International S.A., CH | MBI |
| Oct 16, 2017 | K172186 | BioWick X Implant with Driver Cayenne Medical, Inc. | MBI |
| Sep 28, 2017 | K172612 | FiberTak DX Arthex, Inc. | MBI |
| Sep 19, 2017 | K171964 | LigaMetrics Suture Anchors Mortise Medical, LLC | MBI |
| Sep 8, 2017 | K171725 | CuffLink Implant System Conmed Corporation | MBI |
| Aug 24, 2017 | K171465 | Stryker Self-Punching ICONIX Stryker | MBI |
| Aug 17, 2017 | K172165 | Q-Fix Suture Anchor ArthroCare Corporation | MBI |
| Jul 25, 2017 | K170388 | ANCHORMAN Tibial Ligament Fixation Device Summit Medical , Ltd., GB | MBI |
| Jun 2, 2017 | K171060 | OrthoButton AL Riverpoint Medical | MBI |
| Jun 2, 2017 | K170877 | Parcus SLiK Fix Screw Parcus Medical | MBI |
| May 16, 2017 | K171020 | Arthrex Knotless SutureTak Anchor Arthrex, Inc. | MBI |
| Mar 31, 2017 | K170098 | ICONIX TT All Suture Anchor Stryker | MBI |
| Mar 30, 2017 | K170327 | Parcus SLiK Anchors Parcus Medical | MBI |
| Feb 23, 2017 | K170265 | GRAVITYTM PEEK-OPTIMA Suture Anchor Wrightmedicaltechnologyinc | MBI |
| Jan 25, 2017 | K163258 | CrossFT Knotless Suture Anchor with Disposable Driver Conmed Corporation | MBI |
| Dec 7, 2016 | K163034 | SUTUREFIX Curved Suture Anchor Smith and Nephew, Inc. | MBI |
| Nov 18, 2016 | K162198 | GFS Ultimate Parcus Medical, LLC | MBI |
| Oct 25, 2016 | K162386 | KATOR Suture Anchor Kator, LLC | MBI |
| Aug 3, 2016 | K161033 | AFX Femoral Implant With Inserter Cayenne Medical, Inc. | MBI |
| Jul 6, 2016 | K160996 | Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm Dunamis, LLC | MBI |
| Jun 9, 2016 | K161001 | MILAGRO ADVANCE PEEK Interference Screw Medos International SARL, CH | MBI |
| Jun 3, 2016 | K160655 | OrthoButton CL Riverpoint Medical | MBI |
| May 10, 2016 | K160319 | FiberTak DR Arthrex, Inc. | MBI |
| May 5, 2016 | K153585 | Flip Button Suture Anchor First Ray, LLC | MBI |
| May 3, 2016 | K160118 | STROPP (Single Tunnel Repair of Plantar Plate) Crossroads Extremity Systems, LLC | MBI |
| Apr 21, 2016 | K153558 | Ventix Suture Anchor Biomet Manufacturing Corp | MBI |
| Apr 20, 2016 | K160500 | Elite SPK, Compasso, Elite SPK Kit Ncs Lab Srl | MBI |
| Mar 24, 2016 | K153667 | TRUESPAN Meniscal Repair System Medos International SARL, CH | MBI |
| Mar 8, 2016 | K152262 | Ventix Knotless Anchors Biomet Manufacturing Corp | MBI |
| Feb 23, 2016 | K151092 | Arthrex Short Suture Anchors Arthrex, Inc. | MBI |
| Jan 28, 2016 | K153186 | Adjustable Fixation Device Arthrocare Corp. | MBI |
| Jan 19, 2016 | K153669 | MultiFIX S Ultra Knotless Fixation System Arthocare Corporation | MBI |
| Dec 11, 2015 | K153313 | SpeedLock Knotless Fixation System ArthroCare Corporation | MBI |
| Dec 2, 2015 | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT Smith & Nephew, Inc. | MBI |
| Nov 20, 2015 | K152711 | Parcus GFS Naked Parcus Medical, LLC | MBI |
| Nov 17, 2015 | K151004 | PULLUP® Adjustable Juxtacortical Fixation Device Sbm Sciences For Bio Materials, FR | MBI |
| Nov 16, 2015 | K152255 | BoneCam Suture Anchors Valeris Medical | MBI |
| Nov 4, 2015 | K152236 | KATOR Suture Anchor Kator, LLC | MBI |
| Oct 14, 2015 | K151220 | Dunamis Interference Screw Dunamis, LLC | MBI |
| Sep 9, 2015 | K151601 | SECURE-LOOP Xiros, Ltd., GB | MBI |
| Sep 4, 2015 | K150768 | JuggerKnot Soft Anchors Biomet Manufacturing Corp | MBI |
| Aug 20, 2015 | K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm Arthrex, Inc. | MBI |
| Aug 6, 2015 | K151897 | MultiFIX® P Knotless Fixation Device ArthroCare Corporation | MBI |
| Jul 28, 2015 | K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors Tornier, Inc. | MBI |
| Jul 24, 2015 | K151068 | SureLock W Suture Anchor Cayenne Medical, Inc. | MBI |
| Jul 23, 2015 | K151314 | CinchLock Flex Knotless Suture Anchor Pivot Medical | MBI |
| Jul 16, 2015 | K151660 | MultiFIX S Knotless Fixation System ArthroCare Corporation | MBI |
| Jul 9, 2015 | K151037 | GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle Conmed Corporation | MBI |
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