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 |
|---|---|---|---|
| Oct 23, 2026 | K263348 | Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with Smith & Nephew, Inc. | MBI |
| Oct 21, 2026 | K263352 | TeKBrace Knotless Anchor TheraMicro | MBI |
| Sep 17, 2026 | K261869 | Integrity Retractable Implant Inserter (6000127) Anika Therapeutics, Inc. | MBI |
| Sep 2, 2026 | K262809 | ArthroTAK Tendon Anchor Kit ArthroTAK, LLC | MBI |
| Sep 2, 2026 | K253065 | Aevumed SUPERCYNCH Button System Aevumed, Inc. | MBI |
| Aug 27, 2026 | K262677 | Iconix Knotless T Riverpoint Medical | MBI |
| Aug 3, 2026 | K262047 | Grappler Suture Anchor System Paragon 28, Inc. | MBI |
| Jul 30, 2026 | K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down Stryker Endoscopy | MBI |
| Jul 29, 2026 | K261770 | Suture Button Repair System Skeletal Dynamics, Inc. | MBI |
| Jul 20, 2026 | K261632 | Thunderbolt System Responsive Arthroscopy, Inc. | MBI |
| Jul 9, 2026 | K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS Smith & Nephew, Inc. | MBI |
| Jun 26, 2026 | K260018 | Arthrex FiberButton Arthrex, Inc. | MBI |
| May 27, 2026 | K253130 | Dione PEEK Screw System ZheJiang Decans Medical Devices Co., Ltd., CN | MBI |
| May 13, 2026 | K261363 | Y-Knotless Flex Anchors CONMED Corporation | MBI |
| May 6, 2026 | K253027 | Anchor with Fiber Wire and Disposable Inserter Ortobio S.A., BR | MBI |
| May 1, 2026 | K252635 | ArthroTAK Tendon Anchor Kit ArthroTAK, LLC | MBI |
| Apr 21, 2026 | K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line Tigon Medical | MBI |
| Mar 20, 2026 | K260561 | Arthrex FiberTak Suture Anchor Arthrex, Inc. | MBI |
| Mar 17, 2026 | K253886 | Grappler Suture Anchor PCFD Tether System Paragon 28, Inc. | MBI |
| Mar 16, 2026 | K254176 | SINEFIX BAAT Medical Products B.V., NL | MBI |
| Mar 12, 2026 | K251750 | Trax EX Anchor Trax Surgical, Inc. | MBI |
| Mar 11, 2026 | K253693 | Strut Suture; No-Tie Button Riverpoint Medical, LLC | MBI |
| Mar 9, 2026 | K260405 | FiberTape Button Arthrex, Inc. | MBI |
| Mar 6, 2026 | K253538 | TeKBrace Knotless Anchor Theramicro | MBI |
| Mar 4, 2026 | K254306 | Aevumed FENIX Suture Anchor Aevumed, Inc. | MBI |
| Mar 2, 2026 | K254229 | Arthrex Nano FiberTak Suture Anchor Arthrex, Inc. | MBI |
| Feb 27, 2026 | K253695 | LigaMend Riverpoint Medical, LLC | MBI |
| Jan 29, 2026 | K253763 | Y-Knotless Flex Anchors Conmed Corporation | MBI |
| Jan 28, 2026 | K260004 | Aevumed PROTEKT Suture Anchor Aevumed, Inc. | MBI |
| Jan 6, 2026 | K253618 | QuadLock Fixation System Abanza Tecnomed S.L, ES | MBI |
| Dec 30, 2025 | K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm Arthrex, Inc. | MBI |
| Dec 4, 2025 | K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors Tigon Medical | MBI |
| Nov 4, 2025 | K252664 | GMReis Suture Anchors GM Dos Reis Industria e Comercio Ltda., BR | MBI |
| Oct 29, 2025 | K252314 | Arthrex SutureTak Suture Anchor Arthrex, Inc. | MBI |
| Oct 21, 2025 | K253040 | Aevumed FASE Suture Anchor Aevumed, Inc. | MBI |
| Oct 14, 2025 | K253010 | Mini Superhawk Suture Anchor System Responsive Arthroscopy, LLC | MBI |
| Sep 5, 2025 | K250095 | All-Suture Dual Anchor System Suturetech, Inc. | MBI |
| Aug 6, 2025 | K242895 | Aevumed PHANTOM Suture Anchors Aevumed, Inc. | MBI |
| Jul 30, 2025 | K252144 | Iconix Speed Anchor; Iconix Speed HA+ Anchor Riverpoint Medical | MBI |
| Jul 22, 2025 | K251310 | OTS 25-L (100-5) Ots Medical , Ltd., IL | MBI |
| Jul 18, 2025 | K251809 | Arthrex FiberTak Suture Anchor Arthrex, Inc. | MBI |
| Jul 10, 2025 | K251145 | Arthrex PushLock Suture Anchors Arthrex, Inc. | MBI |
| Jul 1, 2025 | K251933 | SnugFit ASA Extension Medacta International S.A., CH | MBI |
| Jun 25, 2025 | K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (# Smith & Nephew, Inc. | MBI |
| Jun 18, 2025 | K251530 | CONMED Argo Knotless® Anchor Conmed Corporation | MBI |
| Jun 2, 2025 | K250844 | PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop Science & Bio Materials (S.B.M.) Sas, FR | MBI |
| May 12, 2025 | K242477 | Shoulder Soft Tissue Anchors Signature Orthopaedics Pty, Ltd., AU | MBI |
| Mar 28, 2025 | K250596 | Arthrex FiberTak Suture Anchor Arthrex, Inc. | MBI |
| Mar 20, 2025 | K243988 | RootMend MRR Riverpoint Medical, LLC | MBI |
| Mar 11, 2025 | K250424 | Arthrex TightRope Soft Button, RT Arthrex, Inc. | MBI |
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