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 |
|---|---|---|---|
| Aug 9, 2023 | K231376 | Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) Smith & Nephew, Inc. | MBI |
| Aug 8, 2023 | K231857 | Arthrex TightRope II Arthrex, Inc. | MBI |
| Aug 4, 2023 | K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobr Smith & Nephew, Inc. | MBI |
| Aug 4, 2023 | K231404 | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Butt Healthium Medtech Limited, IN | MBI |
| Aug 2, 2023 | K223114 | Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors Gm Dos Reis Industria E Comerico Ltda., BR | MBI |
| Aug 1, 2023 | K231278 | Knotless Suture Anchor Riverpoint Medical, LLC | MBI |
| Jun 7, 2023 | K231322 | Fix2Lock(PEEK Self Punching) Osteonic Co., Ltd., KR | MBI |
| Jun 7, 2023 | K231002 | Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture ancho Suzhou Endophix Co., Ltd., CN | MBI |
| Jun 1, 2023 | K231330 | FiberTak® Suture Anchor Arthrex, Inc. | MBI |
| May 23, 2023 | K230874 | Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath Suzhou Endophix Co., Ltd., CN | MBI |
| May 22, 2023 | K223860 | Integrity Bone Staple Fixation System Anika Therapeutics, Inc. | MBI |
| May 18, 2023 | K231113 | Arthrex FiberTak Suture Anchor Arthrex, Inc. | MBI |
| May 17, 2023 | K231128 | JuggerKnot Soft Anchor Riverpoint Medical, LLC | MBI |
| May 3, 2023 | K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw Signature Orthopaedics Pty, Ltd., AU | MBI |
| May 3, 2023 | K230123 | Apollo Knotless Suture Anchor Maruho Medical | MBI |
| Apr 17, 2023 | K230544 | SnugFit All-Suture Anchor extension Medacta International S.A., CH | MBI |
| Apr 1, 2023 | K230568 | FiberTak Suture Anchor Arthrex, Inc. | MBI |
| Mar 23, 2023 | K222423 | Fixone All Suture Anchor Aju Pharm Co., Ltd., KR | MBI |
| Mar 22, 2023 | K223889 | Stativ® Knotted UHMWPE Suture Anchor Healthium Medtech Limited, IN | MBI |
| Mar 22, 2023 | K220464 | Tigon Medical Gryphon Anchor Line Tigon Medical | MBI |
| Mar 17, 2023 | K223878 | Aevumed RAPID Suture Anchors Aevumed, Inc. | MBI |
| Mar 10, 2023 | K230433 | Arthrex Knotless FiberTak Suture Anchor Arthrex, Inc. | MBI |
| Mar 8, 2023 | K220966 | SINEFIX BAAT Medical Products B.V., NL | MBI |
| Mar 3, 2023 | K223589 | Grappler Suture Anchor R3FLEX IOL System Paragon 28, Inc. | MBI |
| Feb 24, 2023 | K223582 | MectaLock TI Triple Loaded Suture Anchor Medacta International S.A., CH | MBI |
| Feb 23, 2023 | K230212 | OrthoButton AL Riverpoint Medical, LLC | MBI |
| Feb 17, 2023 | K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Smith & Nephew, Inc. | MBI |
| Feb 4, 2023 | K222574 | Simparo Anchor Line Fixation System Simparo, Inc. | MBI |
| Feb 2, 2023 | K223284 | SutureLoc Implant Arthrex, Inc. | MBI |
| Jan 26, 2023 | K222589 | Flexible Suturing System with Anchors (FSSA) Integrity Orthopaedics, Inc. | MBI |
| Jan 17, 2023 | K223795 | FairFix QT Adjustable Button Medacta International S.A., CH | MBI |
| Dec 22, 2022 | K221396 | Arthrex FiberTak Suture Anchor Arthrex, Inc. | MBI |
| Dec 16, 2022 | K213110 | AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor Auxein Medical Private Limited, IN | MBI |
| Nov 28, 2022 | K222363 | Aevumed PHANTOM-LP Suture Anchors Aevumed, Inc. | MBI |
| Nov 18, 2022 | K213018 | Auxilock GFS Mini, GFS II Large, and GFS Ultimate Auxein Medical Private Limited, IN | MBI |
| Oct 13, 2022 | K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors Responsive Arthroscopy, LLC | MBI |
| Sep 22, 2022 | K212197 | WasherCap Fixation System Abanza Tecnomed S.L, ES | MBI |
| Sep 14, 2022 | K222091 | Grappler Suture Anchor System Paragon 28, Inc. | MBI |
| Sep 7, 2022 | K221731 | 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 |
| Aug 22, 2022 | K213109 | Auxilock Draw Tight Suture-Based Anchor Auxein Medical Private Limited, IN | MBI |
| Aug 16, 2022 | K222169 | FairFix Adjustable Button System Medacta International S.A., CH | MBI |
| Aug 11, 2022 | K222161 | Arthrex Knotless FiberTak Biceps Suture Anchor Arthrex, Inc. | MBI |
| Jul 29, 2022 | K220901 | S-Core Implant System Subchondral Solutions, Inc. | MBI |
| Jul 29, 2022 | K213104 | Auxilock Titanium Screw-In Suture Anchor Auxein Medical Private Limited, IN | MBI |
| Jul 26, 2022 | K221502 | Parcus Synd-EZ SS Parcus Medical, LLC | MBI |
| Jul 11, 2022 | K221364 | Mitek TIGHT-N Anchor Medos International SARL, CH | MBI |
| Jun 8, 2022 | K221389 | FairFix AM Adjustable Button FairFix PSP Adjustable Button Medacta International S.A., CH | MBI |
| May 19, 2022 | K221135 | X-Twist PEEK Suture Anchor Parcus Medical, LLC | MBI |
| May 13, 2022 | K220757 | Argo Knotless SP Anchor Conmed Corporation | MBI |
| Apr 15, 2022 | K220797 | FootHold System Crossroads Extremity Systems, LLC | MBI |
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