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 |
|---|---|---|---|
| Feb 25, 2025 | K250238 | WasherCap Fixation System Abanza Tecnomed S.L, ES | MBI |
| Feb 19, 2025 | K244015 | SuperBall-RC Arcuro Medical , Ltd., IL | MBI |
| Jan 31, 2025 | K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PE ZheJiang Decans Medical Devices Co., Ltd., CN | MBI |
| Jan 30, 2025 | K243726 | Osprey Suture Anchor Responsive Arthroscopy, Inc. | MBI |
| Jan 30, 2025 | K243712 | WasherCap Mini Fixation System (Model 45) Abanza Tecnomed S.L, ES | MBI |
| Jan 28, 2025 | K244025 | Argo Knotless GENESYS Anchor Conmed Corporation | MBI |
| Jan 23, 2025 | K241234 | OTS 25-L (100-5) Ots Medical , Ltd., IL | MBI |
| Dec 20, 2024 | K242529 | Tigon Medical All-Suture Anchors (ASA) Tigon Medical | MBI |
| Dec 3, 2024 | K243470 | Fix2Lock (PEEK Self Punching) Osteonic Co., Ltd., KR | MBI |
| Nov 26, 2024 | K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct Riverpoint Medical, LLC | MBI |
| Nov 19, 2024 | K243323 | Iconix Knotless Anchor Riverpoint Medical | MBI |
| Oct 29, 2024 | K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor Riverpoint Medical | MBI |
| Sep 12, 2024 | K241695 | Extremity All Suture System Field Orthopaedics, AU | MBI |
| Aug 29, 2024 | K242296 | VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Sut Ortho-Design (Pty), Ltd., ZA | MBI |
| Aug 2, 2024 | K233601 | Fixone Meniscal Repair Aju Pharm Co., Ltd., KR | MBI |
| Jul 25, 2024 | K241864 | Grappler Interference Screw System Paragon 28, Inc. | MBI |
| Jul 19, 2024 | K240835 | Suture Button Repair System Skeletal Dynamics, Inc. | MBI |
| Jul 3, 2024 | K241577 | Iconix® Anchor Riverpoint Medical | MBI |
| Jun 20, 2024 | K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, wi Smith & Nephew, Inc. | MBI |
| May 29, 2024 | K241235 | Arthrex TightRope II Arthrex, Inc. | MBI |
| May 3, 2024 | K232941 | Megaloop Button System Suzhou Endophix Co., Ltd., CN | MBI |
| Apr 11, 2024 | K240719 | OC JuggerKnot Soft Anchor Riverpoint Medical | MBI |
| Mar 26, 2024 | K240594 | Grappler Suture Anchor R3FLEX IOL System Paragon 28, Inc. | MBI |
| Mar 7, 2024 | K240407 | ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor Stryker Endoscopy | MBI |
| Feb 23, 2024 | K240213 | Iconix Knotless Anchor Riverpoint Medical | MBI |
| Feb 21, 2024 | K240194 | ProCinch, QuadCinch Riverpoint Medical | MBI |
| Jan 25, 2024 | K233893 | AlphaVent Knotless SP PEEK Anchor Stryker Endoscopy | MBI |
| Jan 17, 2024 | K233730 | Footprint Mini PK, 3.5mm Suture Anchor Smith & Nephew | MBI |
| Jan 4, 2024 | K231033 | CEPTRE® Knotted UHMWPE Suture PEEK Anchor Healthium Medtech Limited, IN | MBI |
| Dec 28, 2023 | K230891 | SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant Healthium Medtech Limited, IN | MBI |
| Dec 26, 2023 | K233659 | Suture Wing Osteonic Co., Ltd., KR | MBI |
| Dec 7, 2023 | K233429 | OTS 25 (100-1) Ots Medical , Ltd., IL | MBI |
| Nov 30, 2023 | K233552 | IDEAL Ziploop Riverpoint Medical | MBI |
| Nov 15, 2023 | K232973 | Arthrex Knee FiberTak® Button Suture Anchor Arthrex, Inc. | MBI |
| Nov 14, 2023 | K233468 | Iconix Anchor Riverpoint Medical | MBI |
| Nov 8, 2023 | K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button Healthium Medtech Limited, IN | MBI |
| Nov 3, 2023 | K232742 | Arthrex FiberTak Suture Anchor Arthrex, Inc. | MBI |
| Nov 2, 2023 | K232725 | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor Suzhou Endophix Co., Ltd., CN | MBI |
| Oct 24, 2023 | K232683 | Knotilus+ PEEK Knotless Anchor Stryker Endoscopy | MBI |
| Oct 23, 2023 | K233258 | Shadow Knotless All-Suture Anchors Responsive Arthroscopy, LLC | MBI |
| Oct 6, 2023 | K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor Medos International SARL, CH | MBI |
| Oct 6, 2023 | K232411 | JuggerKnot Soft Anchor OC Riverpoint Medical, LLC | MBI |
| Oct 5, 2023 | K231078 | All-Suture Anchor Riverpoint Medical, LLC | MBI |
| Sep 20, 2023 | K232592 | CITRELOCK® DUO Acuitive Technologies, Inc. | MBI |
| Sep 11, 2023 | K230517 | Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, Jarmon Medical, LLC (Dba Legends Orthopedics) | MBI |
| Sep 8, 2023 | K232457 | Q-FIX ULTRA All-Suture Anchor Smith & Nephew | MBI |
| Sep 1, 2023 | K232340 | Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor Arthrex, Inc. | MBI |
| Aug 30, 2023 | K231093 | AlphaVent Suture Anchors Stryker Endoscopy | MBI |
| Aug 25, 2023 | K230094 | Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors Responsive Arthroscopy, LLC | MBI |
| Aug 21, 2023 | K231867 | Grappler Suture Anchor System Paragon 28, Inc. | MBI |
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