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 |
|---|---|---|---|
| Dec 6, 2021 | K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi Ortho-Design (Pty), Ltd., ZA | MBI |
| Oct 6, 2021 | K212739 | ActiFlip Parcus Medical, LLC | MBI |
| Aug 30, 2021 | K211322 | Paratrooper Plantar Plate Repair System Paragon 28, Inc. | MBI |
| Aug 4, 2021 | K211502 | Alpha Vent PEEK Suture Anchor Stryker Endoscopy | MBI |
| Aug 4, 2021 | K211049 | Tigon Medical Button System Tigon Medical | MBI |
| Jul 7, 2021 | K211002 | Grappler Suture Anchor System Paragon 28, Inc. | MBI |
| Jun 7, 2021 | K202663 | Suture Wing Osteonic Co., Ltd., KR | MBI |
| Jun 4, 2021 | K202763 | Fix2Lock (PEEK Self Punching) Osteonic Co., Ltd., KR | MBI |
| Apr 27, 2021 | K203121 | Responsive Arthroscopy Thunderbolt System Responsive Arthroscopy, LLC | MBI |
| Mar 26, 2021 | K203259 | FairFix Adjustable Button System Medacta International S.A., CH | MBI |
| Mar 24, 2021 | K210498 | Betta Link Knotless Implant System T.A.G. Medical Products Corporation, Ltd., IL | MBI |
| Mar 11, 2021 | K210078 | Stryker ProCinch Adjustable Loop Device Stryker Endoscopy | MBI |
| Feb 22, 2021 | K202662 | Parcus Titanium Interference Screws Parcus Medical, LLC | MBI |
| Feb 12, 2021 | K203740 | JuggerKnot Soft Anchor Riverpoint Medical | MBI |
| Feb 11, 2021 | K203385 | TenoTac Soft Tissue Fixation System Paragon 28, Inc. | MBI |
| Feb 1, 2021 | K203794 | HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture Medos International SARL, CH | MBI |
| Jan 19, 2021 | K203485 | SnugFit All-Suture Anchor Medacta International S.A., CH | MBI |
| Jan 8, 2021 | K202291 | Button Loop Yunyi (Beijing) Medical Device Co., Ltd., CN | MBI |
| Dec 15, 2020 | K192709 | Fixone All Suture Anchor Aju Pharm Co., Ltd., KR | MBI |
| Nov 27, 2020 | K203268 | Arthrex FiberTak Suture Anchor Arthrex, Inc. | MBI |
| Nov 25, 2020 | K202883 | Sterile bone screw (PEEK ACL screw) Osteonic Co., Ltd., KR | MBI |
| Nov 25, 2020 | K193377 | TopLock Anchor System Fusion Orthopedics, LLC | MBI |
| Nov 17, 2020 | K202444 | Knotless TensionTight Button Implant System Arthrex, Inc. | MBI |
| Nov 13, 2020 | K202355 | Stryker Omega PEEK Knotless Anchor System Stryker | MBI |
| Nov 13, 2020 | K202178 | VersaLoop Anchor System T.A.G. Medical Products Corporation, Ltd., IL | MBI |
| Nov 10, 2020 | K200428 | Multi-Drive Interference Screw System Nvision Biomedical Technologies, Inc. | MBI |
| Nov 10, 2020 | K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist Biomet, Inc. | MBI |
| Nov 4, 2020 | K202581 | Arthrex TightRope II Arthrex, Inc. | MBI |
| Oct 28, 2020 | K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actifli Parcus Medical, LLC | MBI |
| Oct 16, 2020 | K202193 | PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament R S.B.M. Sas (Science & Bio Materials), FR | MBI |
| Oct 7, 2020 | K192949 | Flower Suture Anchor Set Flower Orthopedics Corporation | MBI |
| Sep 18, 2020 | K202399 | OrthoButton FL Riverpoint Medical | MBI |
| Sep 9, 2020 | K202153 | Responsive Arthroscopy Suture Anchor System Responsive Arthroscopy, LLC | MBI |
| Sep 2, 2020 | K200503 | ATL Anchors International Life Sciences | MBI |
| Aug 20, 2020 | K201636 | Hercules Suture Anchor System In2bones USA, LLC | MBI |
| Aug 7, 2020 | K201883 | 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor Medos International SARL, CH | MBI |
| Jul 23, 2020 | K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors Parcus Medical, LLC | MBI |
| Jun 4, 2020 | K200949 | HEALIX ADVANCE Anchor with DYNATAPE Suture Medos International SARL, CH | MBI |
| Mar 26, 2020 | K193108 | Bonecam Suture Anchor Valeris Medical, Inc. | MBI |
| Mar 12, 2020 | K200341 | Arthrex FiberTak Suture Anchor Arthrex, Inc. | MBI |
| Mar 11, 2020 | K192810 | Apollo Suture Anchor System Valeris Medical | MBI |
| Mar 5, 2020 | K193402 | ALLthread PEEK Suture Anchor Biomet, Inc. | MBI |
| Mar 4, 2020 | K200028 | Coronet Soft Tissue Fixation System Conextions Medical | MBI |
| Feb 14, 2020 | K193245 | Dunamis PunchTac Suture Anchors Dunamis, LLC | MBI |
| Feb 10, 2020 | K193165 | MectaFix CL Fixation Button with Continuous Loop Medacta International S.A., CH | MBI |
| Feb 6, 2020 | K193461 | MectaLock All-Suture Anchors Medacta International S.A., CH | MBI |
| Jan 29, 2020 | K191677 | MectaTap TI Suture Anchor Medacta International S.A., CH | MBI |
| Jan 24, 2020 | K191227 | Paratrooper Plantar Plate Repair System Paragon 28, Inc. | MBI |
| Jan 23, 2020 | K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor Parcus Medical, LLC | MBI |
| Jan 22, 2020 | K193606 | Y-Knot OneStep Anchor Conmed Corporation | MBI |
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