Fastener, Fixation, Nondegradable, Soft Tissue
FDA product code MBI · Class II (moderate risk) · 21 CFR 888.3040 · Orthopedic
603510(k) clearances
0PMA approvals
113recalls
Implantimplanted device
Manufacturers
- Arthrex, Inc. 52
- Arthrocare Corp. 31
- Parcus Medical, LLC 23
- Riverpoint Medical, LLC 23
- Innovasive Devices, Inc. 22
- Smith & Nephew, Inc. 22
- Conmed Corporation 16
- Medacta International S.A. 15
- Cayenne Medical, Inc. 14
- Paragon 28, Inc. 13
- Wrightmedicaltechnologyinc 11
- Responsive Arthroscopy, LLC 11
- Stryker Endoscopy 11
- Medos International SARL 11
- Biomet, Inc. 10
- Linvatec Corp. 10
- Stryker Corporation 10
- Aevumed, Inc. 8
- Biomet Sports Medicine 8
- Tornier, Inc. 7
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262809 | ArthroTAK Tendon Anchor KitMBI · Special | ArthroTAK, LLC | 09/02/2026SE |
| K253065 | Aevumed SUPERCYNCH Button SystemMBI · Traditional | Aevumed, Inc. | 09/02/2026SE |
| K262677 | Iconix Knotless TMBI · Special | Riverpoint Medical | 08/27/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | Paragon 28, Inc. | 08/03/2026SE |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special | Stryker Endoscopy | 07/30/2026SE |
| K261770 | Suture Button Repair SystemMBI · Traditional | Skeletal Dynamics, Inc. | 07/29/2026SE |
| K261632 | Thunderbolt SystemMBI · Special | Responsive Arthroscopy, Inc. | 07/20/2026SE |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special | Smith & Nephew, Inc. | 07/09/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | Arthrex, Inc. | 06/26/2026SE |
| K253130 | Dione PEEK Screw SystemMBI · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/27/2026SE |
| K261363 | Y-Knotless Flex AnchorsMBI · Special | CONMED Corporation | 05/13/2026SE |
| K253027 | Anchor with Fiber Wire and Disposable InserterMBI · Traditional | Ortobio S.A. | 05/06/2026SE |
| K252635 | ArthroTAK Tendon Anchor KitMBI · Traditional | ArthroTAK, LLC | 05/01/2026SE |
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineMBI · Special | Tigon Medical | 04/21/2026SE |
| K260561 | Arthrex FiberTak Suture AnchorMBI · Special | Arthrex, Inc. | 03/20/2026SE |
| K253886 | Grappler Suture Anchor PCFD Tether SystemMBI · Traditional | Paragon 28, Inc. | 03/17/2026SE |
| K254176 | SinefixMBI · Special | BAAT Medical Products B.V. | 03/16/2026SE |
| K251750 | Trax EX AnchorMBI · Traditional | Trax Surgical, Inc. | 03/12/2026SE |
| K253693 | Strut Suture; No-Tie ButtonMBI · Traditional | Riverpoint Medical, LLC | 03/11/2026SE |
| K260405 | FiberTape ButtonMBI · Special | Arthrex, Inc. | 03/09/2026SE |
| K253538 | TeKBrace Knotless AnchorMBI · Traditional | Theramicro | 03/06/2026SE |
| K254306 | Aevumed FENIX Suture AnchorMBI · Traditional | Aevumed, Inc. | 03/04/2026SE |
| K254229 | Arthrex Nano FiberTak Suture AnchorMBI · Traditional | Arthrex, Inc. | 03/02/2026SE |
| K253695 | LigaMendMBI · Traditional | Riverpoint Medical, LLC | 02/27/2026SE |
| K253763 | Y-Knotless Flex AnchorsMBI · Special | Conmed Corporation | 01/29/2026SE |
| K260004 | Aevumed PROTEKT Suture AnchorMBI · Special | Aevumed, Inc. | 01/28/2026SE |
| K253618 | QuadLock Fixation SystemMBI · Traditional | Abanza Tecnomed S.L | 01/06/2026SE |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmMBI · Special | Arthrex, Inc. | 12/30/2025SE |
| K252596 | Tigon Medical Knotless and Dual Javelin All-Suture AnchorsMBI · Traditional | Tigon Medical | 12/04/2025SE |
| K252664 | GMReis Suture AnchorsMBI · Traditional | GM Dos Reis Industria e Comercio Ltda. | 11/04/2025SE |
| K252314 | Arthrex SutureTak Suture AnchorMBI · Traditional | Arthrex, Inc. | 10/29/2025SE |
| K253040 | Aevumed FASE Suture AnchorMBI · Special | Aevumed, Inc. | 10/21/2025SE |
| K253010 | Mini Superhawk Suture Anchor SystemMBI · Special | Responsive Arthroscopy, LLC | 10/14/2025SE |
| K250095 | All-Suture Dual Anchor SystemMBI · Traditional | Suturetech, Inc. | 09/05/2025SE |
| K242895 | Aevumed PHANTOM Suture AnchorsMBI · Traditional | Aevumed, Inc. | 08/06/2025SE |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ AnchorMBI · Special | Riverpoint Medical | 07/30/2025SE |
| K251310 | Ots 25-L (100-5)MBI · Traditional | Ots Medical , Ltd. | 07/22/2025SE |
| K251809 | Arthrex FiberTak Suture AnchorMBI · Traditional | Arthrex, Inc. | 07/18/2025SE |
| K251145 | Arthrex PushLock Suture AnchorsMBI · Traditional | Arthrex, Inc. | 07/10/2025SE |
| K251933 | SnugFit ASA ExtensionMBI · Special | Medacta International S.A. | 07/01/2025SE |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | Smith & Nephew, Inc. | 06/25/2025SE |
| K251530 | CONMED Argo Knotless® AnchorMBI · Special | Conmed Corporation | 06/18/2025SE |
| K250844 | PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip…MBI · Traditional | Science & Bio Materials (S.B.M.) Sas | 06/02/2025SE |
| K242477 | Shoulder Soft Tissue AnchorsMBI · Traditional | Signature Orthopaedics Pty, Ltd. | 05/12/2025SE |
| K250596 | Arthrex FiberTak Suture AnchorMBI · Special | Arthrex, Inc. | 03/28/2025SE |
| K243988 | RootMend MRRMBI · Traditional | Riverpoint Medical, LLC | 03/20/2025SE |
| K250424 | Arthrex TightRope Soft Button, RTMBI · Special | Arthrex, Inc. | 03/11/2025SE |
| K250238 | WasherCap Fixation SystemMBI · Special | Abanza Tecnomed S.L | 02/25/2025SE |
| K244015 | SuperBall-RCMBI · Traditional | Arcuro Medical , Ltd. | 02/19/2025SE |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…MBI · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 01/31/2025SE |
| K243726 | Osprey Suture AnchorMBI · Traditional | Responsive Arthroscopy, Inc. | 01/30/2025SE |
| K243712 | WasherCap Mini Fixation System (Model 45)MBI · Traditional | Abanza Tecnomed S.L | 01/30/2025SE |
| K244025 | Argo Knotless GENESYS AnchorMBI · Special | Conmed Corporation | 01/28/2025SE |
| K241234 | Ots 25-L (100-5)MBI · Traditional | Ots Medical , Ltd. | 01/23/2025SE |
| K242529 | Tigon Medical All-Suture Anchors (ASA)MBI · Traditional | Tigon Medical | 12/20/2024SE |
| K243470 | Fix2Lock (PEEK Self Punching)MBI · Special | Osteonic Co., Ltd. | 12/03/2024SE |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructMBI · Traditional | Riverpoint Medical, LLC | 11/26/2024SE |
| K243323 | Iconix Knotless AnchorMBI · Special | Riverpoint Medical | 11/19/2024SE |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorMBI · Special | Riverpoint Medical | 10/29/2024SE |
| K241695 | Extremity All Suture SystemMBI · Traditional | Field Orthopaedics | 09/12/2024SE |
| K242296 | VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture…MBI · Special | Ortho-Design (Pty), Ltd. | 08/29/2024SE |
| K233601 | Fixone Meniscal RepairMBI · Traditional | Aju Pharm Co., Ltd. | 08/02/2024SE |
| K241864 | Grappler Interference Screw SystemMBI · Special | Paragon 28, Inc. | 07/25/2024SE |
| K240835 | Suture Button Repair SystemMBI · Traditional | Skeletal Dynamics, Inc. | 07/19/2024SE |
| K241577 | Iconix® AnchorMBI · Special | Riverpoint Medical | 07/03/2024SE |
| K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX…MBI · Special | Smith & Nephew, Inc. | 06/20/2024SE |
| K241235 | Arthrex TightRope IIMBI · Special | Arthrex, Inc. | 05/29/2024SE |
| K232941 | Megaloop Button SystemMBI · Traditional | Suzhou Endophix Co., Ltd. | 05/03/2024SE |
| K240719 | OC JuggerKnot Soft AnchorMBI · Special | Riverpoint Medical | 04/11/2024SE |
| K240594 | Grappler Suture Anchor R3FLEX IOL SystemMBI · Special | Paragon 28, Inc. | 03/26/2024SE |
| K240407 | ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…MBI · Special | Stryker Endoscopy | 03/07/2024SE |
| K240213 | Iconix Knotless AnchorMBI · Special | Riverpoint Medical | 02/23/2024SE |
| K240194 | ProCinch, QuadCinchMBI · Special | Riverpoint Medical | 02/21/2024SE |
| K233893 | AlphaVent Knotless SP PEEK AnchorMBI · Traditional | Stryker Endoscopy | 01/25/2024SE |
| K233730 | Footprint Mini PK, 3.5mm Suture AnchorMBI · Traditional | Smith & Nephew | 01/17/2024SE |
| K231033 | CEPTRE® Knotted UHMWPE Suture PEEK AnchorMBI · Traditional | Healthium Medtech Limited | 01/04/2024SE |
| K230891 | SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair ImplantMBI · Traditional | Healthium Medtech Limited | 12/28/2023SE |
| K233659 | Suture WingMBI · Special | Osteonic Co., Ltd. | 12/26/2023SE |
| K233429 | Ots 25 (100-1)MBI · Traditional | Ots Medical , Ltd. | 12/07/2023SE |
| K233552 | IDEAL ZiploopMBI · Special | Riverpoint Medical | 11/30/2023SE |
| K232973 | Arthrex Knee FiberTak® Button Suture AnchorMBI · Traditional | Arthrex, Inc. | 11/15/2023SE |
| K233468 | Iconix AnchorMBI · Special | Riverpoint Medical | 11/14/2023SE |
| K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonMBI · Traditional | Healthium Medtech Limited | 11/08/2023SE |
| K232742 | Arthrex FiberTak Suture AnchorMBI · Traditional | Arthrex, Inc. | 11/03/2023SE |
| K232725 | Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorMBI · Traditional | Suzhou Endophix Co., Ltd. | 11/02/2023SE |
| K232683 | Knotilus+ PEEK Knotless AnchorMBI · Traditional | Stryker Endoscopy | 10/24/2023SE |
| K233258 | Shadow Knotless All-Suture AnchorsMBI · Special | Responsive Arthroscopy, LLC | 10/23/2023SE |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite…MBI · Traditional | Medos International SARL | 10/06/2023SE |
| K232411 | JuggerKnot Soft Anchor OCMBI · Traditional | Riverpoint Medical, LLC | 10/06/2023SE |
| K231078 | All-Suture AnchorMBI · Traditional | Riverpoint Medical, LLC | 10/05/2023SE |
| K232592 | Citrelock® DuoMBI · Special | Acuitive Technologies, Inc. | 09/20/2023SE |
| K230517 | Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…MBI · Traditional | Jarmon Medical, LLC (Dba Legends Orthopedics) | 09/11/2023SE |
| K232457 | Q-FIX ULTRA All-Suture AnchorMBI · Special | Smith & Nephew | 09/08/2023SE |
| K232340 | Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorMBI · Special | Arthrex, Inc. | 09/01/2023SE |
| K231093 | AlphaVent Suture AnchorsMBI · Traditional | Stryker Endoscopy | 08/30/2023SE |
| K230094 | Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsMBI · Traditional | Responsive Arthroscopy, LLC | 08/25/2023SE |
| K231867 | Grappler Suture Anchor SystemMBI · Traditional | Paragon 28, Inc. | 08/21/2023SE |
| K231376 | Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)MBI · Traditional | Smith & Nephew, Inc. | 08/09/2023SE |
| K231857 | Arthrex TightRope IIMBI · Traditional | Arthrex, Inc. | 08/08/2023SE |
| K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…MBI · Special | Smith & Nephew, Inc. | 08/04/2023SE |
| K231404 | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…MBI · Traditional | Healthium Medtech Limited | 08/04/2023SE |
| K223114 | Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsMBI · Traditional | Gm Dos Reis Industria E Comerico Ltda. | 08/02/2023SE |
| K231278 | Knotless Suture AnchorMBI · Traditional | Riverpoint Medical, LLC | 08/01/2023SE |
| K231322 | Fix2Lock(PEEK Self Punching)MBI · Special | Osteonic Co., Ltd. | 06/07/2023SE |
| K231002 | Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…MBI · Traditional | Suzhou Endophix Co., Ltd. | 06/07/2023SE |
| K231330 | FiberTak® Suture AnchorMBI · Special | Arthrex, Inc. | 06/01/2023SE |
| K230874 | Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathMBI · Traditional | Suzhou Endophix Co., Ltd. | 05/23/2023SE |
| K223860 | Integrity Bone Staple Fixation SystemMBI · Traditional | Anika Therapeutics, Inc. | 05/22/2023SE |
| K231113 | Arthrex FiberTak Suture AnchorMBI · Special | Arthrex, Inc. | 05/18/2023SE |
| K231128 | JuggerKnot Soft AnchorMBI · Special | Riverpoint Medical, LLC | 05/17/2023SE |
| K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewMBI · Traditional | Signature Orthopaedics Pty, Ltd. | 05/03/2023SE |
| K230123 | Apollo Knotless Suture AnchorMBI · Traditional | Maruho Medical | 05/03/2023SE |
| K230544 | SnugFit All-Suture Anchor extensionMBI · Special | Medacta International S.A. | 04/17/2023SE |
| K230568 | FiberTak Suture AnchorMBI · Special | Arthrex, Inc. | 04/01/2023SE |
| K222423 | Fixone All Suture AnchorMBI · Special | Aju Pharm Co., Ltd. | 03/23/2023SE |
| K223889 | Stativ® Knotted UHMWPE Suture AnchorMBI · Traditional | Healthium Medtech Limited | 03/22/2023SE |
| K220464 | Tigon Medical Gryphon Anchor LineMBI · Traditional | Tigon Medical | 03/22/2023SE |
| K223878 | Aevumed RAPID Suture AnchorsMBI · Traditional | Aevumed, Inc. | 03/17/2023SE |
| K230433 | Arthrex Knotless FiberTak Suture AnchorMBI · Special | Arthrex, Inc. | 03/10/2023SE |
| K220966 | SinefixMBI · Traditional | BAAT Medical Products B.V. | 03/08/2023SE |
| K223589 | Grappler Suture Anchor R3FLEX IOL SystemMBI · Traditional | Paragon 28, Inc. | 03/03/2023SE |
| K223582 | MectaLock TI Triple Loaded Suture AnchorMBI · Traditional | Medacta International S.A. | 02/24/2023SE |
| K230212 | OrthoButton ALMBI · Special | Riverpoint Medical, LLC | 02/23/2023SE |
| K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…MBI · Traditional | Smith & Nephew, Inc. | 02/17/2023SE |
| K222574 | Simparo Anchor Line Fixation SystemMBI · Traditional | Simparo, Inc. | 02/04/2023SE |
| K223284 | SutureLoc ImplantMBI · Traditional | Arthrex, Inc. | 02/02/2023SE |
| K222589 | Flexible Suturing System with Anchors (FSSA)MBI · Traditional | Integrity Orthopaedics, Inc. | 01/26/2023SE |
| K223795 | FairFix QT Adjustable ButtonMBI · Special | Medacta International S.A. | 01/17/2023SE |
| K221396 | Arthrex FiberTak Suture AnchorMBI · Traditional | Arthrex, Inc. | 12/22/2022SE |
| K213110 | AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorMBI · Traditional | Auxein Medical Private Limited | 12/16/2022SE |
| K222363 | Aevumed PHANTOM-LP Suture AnchorsMBI · Traditional | Aevumed, Inc. | 11/28/2022SE |
| K213018 | Auxilock GFS Mini, GFS II Large, and GFS UltimateMBI · Traditional | Auxein Medical Private Limited | 11/18/2022SE |
| K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsMBI · Special | Responsive Arthroscopy, LLC | 10/13/2022SE |
| K212197 | WasherCap Fixation SystemMBI · Traditional | Abanza Tecnomed S.L | 09/22/2022SE |
| K222091 | Grappler Suture Anchor SystemMBI · Traditional | Paragon 28, Inc. | 09/14/2022SE |
| K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…MBI · Traditional | T.A.G. Medical Products Corporation, Ltd. | 09/07/2022SE |
| K213109 | Auxilock Draw Tight Suture-Based AnchorMBI · Traditional | Auxein Medical Private Limited | 08/22/2022SE |
| K222169 | FairFix Adjustable Button SystemMBI · Special | Medacta International S.A. | 08/16/2022SE |
| K222161 | Arthrex Knotless FiberTak Biceps Suture AnchorMBI · Special | Arthrex, Inc. | 08/11/2022SE |
| K220901 | S-Core Implant SystemMBI · Traditional | Subchondral Solutions, Inc. | 07/29/2022SE |
| K213104 | Auxilock Titanium Screw-In Suture AnchorMBI · Traditional | Auxein Medical Private Limited | 07/29/2022SE |
| K221502 | Parcus Synd-EZ SSMBI · Traditional | Parcus Medical, LLC | 07/26/2022SE |
| K221364 | Mitek TIGHT-N AnchorMBI · Traditional | Medos International SARL | 07/11/2022SE |
| K221389 | FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMBI · Special | Medacta International S.A. | 06/08/2022SE |
| K221135 | X-Twist PEEK Suture AnchorMBI · Special | Parcus Medical, LLC | 05/19/2022SE |
| K220757 | Argo Knotless SP AnchorMBI · Traditional | Conmed Corporation | 05/13/2022SE |
| K220797 | FootHold SystemMBI · Traditional | Crossroads Extremity Systems, LLC | 04/15/2022SE |
| K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTiMBI · Traditional | Ortho-Design (Pty), Ltd. | 12/06/2021SE |
| K212739 | ActiFlipMBI · Traditional | Parcus Medical, LLC | 10/06/2021SE |
| K211322 | Paratrooper Plantar Plate Repair SystemMBI · Traditional | Paragon 28, Inc. | 08/30/2021SE |
| K211502 | Alpha Vent PEEK Suture AnchorMBI · Traditional | Stryker Endoscopy | 08/04/2021SE |
| K211049 | Tigon Medical Button SystemMBI · Traditional | Tigon Medical | 08/04/2021SE |
| K211002 | Grappler Suture Anchor SystemMBI · Traditional | Paragon 28, Inc. | 07/07/2021SE |
| K202663 | Suture WingMBI · Traditional | Osteonic Co., Ltd. | 06/07/2021SE |
| K202763 | Fix2Lock (PEEK Self Punching)MBI · Traditional | Osteonic Co., Ltd. | 06/04/2021SE |
| K203121 | Responsive Arthroscopy Thunderbolt SystemMBI · Traditional | Responsive Arthroscopy, LLC | 04/27/2021SE |
| K203259 | FairFix Adjustable Button SystemMBI · Traditional | Medacta International S.A. | 03/26/2021SE |
| K210498 | Betta Link Knotless Implant SystemMBI · Special | T.A.G. Medical Products Corporation, Ltd. | 03/24/2021SE |
| K210078 | Stryker ProCinch Adjustable Loop DeviceMBI · Traditional | Stryker Endoscopy | 03/11/2021SE |
| K202662 | Parcus Titanium Interference ScrewsMBI · Traditional | Parcus Medical, LLC | 02/22/2021SE |
| K203740 | JuggerKnot Soft AnchorMBI · Traditional | Riverpoint Medical | 02/12/2021SE |
| K203385 | TenoTac Soft Tissue Fixation SystemMBI · Traditional | Paragon 28, Inc. | 02/11/2021SE |
| K203794 | HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMBI · Special | Medos International SARL | 02/01/2021SE |
| K203485 | SnugFit All-Suture AnchorMBI · Traditional | Medacta International S.A. | 01/19/2021SE |
| K202291 | Button LoopMBI · Traditional | Yunyi (Beijing) Medical Device Co., Ltd. | 01/08/2021SE |
| K192709 | Fixone All Suture AnchorMBI · Traditional | Aju Pharm Co., Ltd. | 12/15/2020SE |
| K203268 | Arthrex FiberTak Suture AnchorMBI · Special | Arthrex, Inc. | 11/27/2020SE |
| K202883 | Sterile bone screw (PEEK ACL screw)MBI · Traditional | Osteonic Co., Ltd. | 11/25/2020SE |
| K193377 | TopLock Anchor SystemMBI · Traditional | Fusion Orthopedics, LLC | 11/25/2020SE |
| K202444 | Knotless TensionTight Button Implant SystemMBI · Special | Arthrex, Inc. | 11/17/2020SE |
| K202355 | Stryker Omega PEEK Knotless Anchor SystemMBI · Traditional | Stryker | 11/13/2020SE |
| K202178 | VersaLoop Anchor SystemMBI · Traditional | T.A.G. Medical Products Corporation, Ltd. | 11/13/2020SE |
| K200428 | Multi-Drive Interference Screw SystemMBI · Traditional | Nvision Biomedical Technologies, Inc. | 11/10/2020SE |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…MBI · Traditional | Biomet, Inc. | 11/10/2020SE |
| K202581 | Arthrex TightRope IIMBI · Traditional | Arthrex, Inc. | 11/04/2020SE |
| K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…MBI · Traditional | Parcus Medical, LLC | 10/28/2020SE |
| K202193 | PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…MBI · Special | S.B.M. Sas (Science & Bio Materials) | 10/16/2020SE |
| K192949 | Flower Suture Anchor SetMBI · Traditional | Flower Orthopedics Corporation | 10/07/2020SE |
| K202399 | OrthoButton FLMBI · Special | Riverpoint Medical | 09/18/2020SE |
| K202153 | Responsive Arthroscopy Suture Anchor SystemMBI · Special | Responsive Arthroscopy, LLC | 09/09/2020SE |
| K200503 | ATL AnchorsMBI · Traditional | International Life Sciences | 09/02/2020SE |
| K201636 | Hercules Suture Anchor SystemMBI · Traditional | In2bones USA, LLC | 08/20/2020SE |
| K201883 | 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMBI · Special | Medos International SARL | 08/07/2020SE |
| K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsMBI · Traditional | Parcus Medical, LLC | 07/23/2020SE |
| K200949 | HEALIX ADVANCE Anchor with DYNATAPE SutureMBI · Traditional | Medos International SARL | 06/04/2020SE |
| K193108 | Bonecam Suture AnchorMBI · Special | Valeris Medical, Inc. | 03/26/2020SE |
| K200341 | Arthrex FiberTak Suture AnchorMBI · Special | Arthrex, Inc. | 03/12/2020SE |
| K192810 | Apollo Suture Anchor SystemMBI · Special | Valeris Medical | 03/11/2020SE |
| K193402 | ALLthread PEEK Suture AnchorMBI · Traditional | Biomet, Inc. | 03/05/2020SE |
| K200028 | Coronet Soft Tissue Fixation SystemMBI · Traditional | Conextions Medical | 03/04/2020SE |
| K193245 | Dunamis PunchTac Suture AnchorsMBI · Special | Dunamis, LLC | 02/14/2020SE |
| K193165 | MectaFix CL Fixation Button with Continuous LoopMBI · Traditional | Medacta International S.A. | 02/10/2020SE |
| K193461 | MectaLock All-Suture AnchorsMBI · Traditional | Medacta International S.A. | 02/06/2020SE |
| K191677 | MectaTap TI Suture AnchorMBI · Traditional | Medacta International S.A. | 01/29/2020SE |
| K191227 | Paratrooper Plantar Plate Repair SystemMBI · Traditional | Paragon 28, Inc. | 01/24/2020SE |
| K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorMBI · Special | Parcus Medical, LLC | 01/23/2020SE |
| K193606 | Y-Knot OneStep AnchorMBI · Special | Conmed Corporation | 01/22/2020SE |
| K192942 | ALLthread Titanium Suture AnchorMBI · Traditional | Biomet, Inc. | 01/16/2020SE |
| K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipMBI · Traditional | Parcus Medical, LLC | 01/16/2020SE |
| K193092 | TunneLoc Tibial Fixation DeviceMBI · Traditional | Biomet, Inc. | 01/02/2020SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0212-2026 Class II | BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834…There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant… | Biomet, Inc. | 09/23/2025Open, Classified |
| Z-2619-2025 Class II | Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the… | Biomet, Inc. | 09/09/2025Open, Classified |
| Z-1328-2025 Class II | Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile…Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in… | Stryker Corporation | 01/29/2025Open, Classified |
| Z-0581-2025 Class II | BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. | Smith & Nephew Inc. | 10/29/2024Open, Classified |
| Z-0518-2024 Class II | Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless…Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures… | Riverpoint Medical, LLC | 10/25/2023Open, Classified |
| Z-2645-2023 Class II | Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462Expired Product distributed | Stryker Corporation | 08/23/2023Open, Classified |
| Z-2061-2023 Class II | BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in…Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential… | T.A.G. Medical Products Corporation, Ltd. | 05/04/2023Open, Classified |
| Z-2060-2023 Class II | BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in…Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential… | T.A.G. Medical Products Corporation, Ltd. | 05/04/2023Open, Classified |
| Z-1776-2022 Class II | Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use…Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in… | Paragon 28, Inc. | 07/13/2022Open, Classified |
| Z-0630-2021 Class II | Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | Biomet, Inc. | 11/25/2020Terminated |
| Z-2746-2020 Class II | SUTUREFIX ULTRA Suture, Product number 72203855A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one… | Smith & Nephew, Inc. | 06/24/2020Open, Classified |
| Z-2539-2020 Class II | OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number…ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size.… | OrthoPediatrics Corp | 06/05/2020Terminated |
| Z-2538-2020 Class II | OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number…ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size.… | OrthoPediatrics Corp | 06/05/2020Terminated |
| Z-1757-2020 Class II | Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902Space between the device and the packaging permits excessive movement which could potentially lead to the… | Smith & Nephew, Inc. | 03/17/2020Open, Classified |
| Z-1756-2020 Class II | Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901Space between the device and the packaging permits excessive movement which could potentially lead to the… | Smith & Nephew, Inc. | 03/17/2020Open, Classified |
| Z-1273-2020 Class II | TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to…Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube… | Smith & Nephew, Inc. | 12/30/2019Terminated |
| Z-1148-2020 Class II | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI…Complaints have been received regarding difficulty in removing the driver from the screw. High driver… | Stryker Corporation | 07/19/2019Terminated |
| Z-1147-2020 Class II | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472…Complaints have been received regarding difficulty in removing the driver from the screw. High driver… | Stryker Corporation | 07/19/2019Terminated |
| Z-0724-2019 Class II | Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled…Potentially lead to anchor breakage during insertion, | Arthrex, Inc. | 11/19/2018Open, Classified |
| Z-3252-2018 Class II | Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to…Expiration date incorrectly listed on the label | Zimmer Biomet, Inc. | 08/03/2018Terminated |
| Z-0104-2019 Class II | Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each…The product was mislabeled as containing the incorrect type of suture. | Valeris Medical, LLC | 07/16/2018Terminated |
| Z-2430-2018 Class II | Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended…The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the… | Valeris Medical, LLC | 01/22/2018Terminated |
| Z-1009-2018 Class II | fastener, fixation, nondegradable, soft tissueIt was identified that the product was not assembled correctly causing the implant shaft to shift and fall… | Zimmer Biomet, Inc. | 10/25/2017Terminated |
| Z-1072-2018 Class II | TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation…Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate. | Zimmer Biomet, Inc. | 10/11/2017Terminated |
| Z-1071-2018 Class II | TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts…Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate. | Zimmer Biomet, Inc. | 10/11/2017Terminated |
| Z-0818-2018 Class II | Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for…Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors. | Zimmer Biomet, Inc. | 08/22/2017Terminated |
| Z-0253-2018 Class II | Nonabsorbable suture anchor system intended to reattach soft tissue to bone in…Manufactured with the incorrect anchor outer body | ConMed Corporation | 04/17/2017Terminated |
| Z-2138-2016 Class II | Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft TissueDePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled… | Synthes (USA) Products LLC | 05/31/2016Terminated |
| Z-1635-2016 Class II | CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The…Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor… | Stryker Corporation | 04/12/2016Terminated |
| Z-1634-2016 Class II | CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot…Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor… | Stryker Corporation | 04/12/2016Terminated |
| Z-1828-2016 Class II | Various trauma and sports medicine instruments and implants. Fastener, fixation…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | Biomet, Inc. | 04/01/2016Terminated |
| Z-2214-2015 Class II | Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor; Pouch…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-2560-2014 Class II | ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm…Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. | OrthoPediatrics Corp | 07/25/2014Terminated |
| Z-2049-2014 Class II | SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation…Sterility of device is compromised due to breach in sterile barrier | Smith & Nephew, Inc. Endoscopy Division | 06/02/2014Terminated |
| Z-2048-2014 Class II | SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853…Sterility of device is compromised due to breach in sterile barrier | Smith & Nephew, Inc. Endoscopy Division | 06/02/2014Terminated |
| Z-2047-2014 Class II | SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation…Sterility of device is compromised due to breach in sterile barrier | Smith & Nephew, Inc. Endoscopy Division | 06/02/2014Terminated |
| Z-2046-2014 Class II | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842…Sterility of device is compromised due to breach in sterile barrier | Smith & Nephew, Inc. Endoscopy Division | 06/02/2014Terminated |
| Z-2045-2014 Class II | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener…Sterility of device is compromised due to breach in sterile barrier | Smith & Nephew, Inc. Endoscopy Division | 06/02/2014Terminated |
| Z-0579-2014 Class II | OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL…Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6… | OrthoPediatrics Corp | 11/07/2013Terminated |
| Z-0364-2014 Class II | Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The…Investigation identified that the design of the drill bit may make the suture anchor difficult to insert… | Biomet, Inc. | 10/10/2013Terminated |
| Z-1276-2013 Class II | ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of…Expiration date on the patient label and date on the product carton were not the same. | Medshape Solutions, INC. | 04/04/2013Terminated |
| Z-1916-2014 Class II | ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | The Anspach Effort, Inc. | 11/28/2012Terminated |
| Z-1915-2014 Class II | ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | The Anspach Effort, Inc. | 11/28/2012Terminated |
| Z-1876-2014 Class II | ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | The Anspach Effort, Inc. | 11/28/2012Terminated |
| Z-1875-2014 Class II | ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and… | The Anspach Effort, Inc. | 11/28/2012Terminated |
| Z-2168-2012 Class II | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID-…Distal part of the anchor may break on insertion into bone during surgery | Smith & Nephew, Inc. Endoscopy Division | 07/03/2012Terminated |
| Z-2167-2012 Class II | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue…Distal part of the anchor may break on insertion into bone during surgery | Smith & Nephew, Inc. Endoscopy Division | 07/03/2012Terminated |
| Z-2166-2012 Class II | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue)…Distal part of the anchor may break on insertion into bone during surgery | Smith & Nephew, Inc. Endoscopy Division | 07/03/2012Terminated |
| Z-2165-2012 Class II | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures…Distal part of the anchor may break on insertion into bone during surgery | Smith & Nephew, Inc. Endoscopy Division | 07/03/2012Terminated |
| Z-0068-2013 Class II | NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To…Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211… | Linvatec Corp. dba ConMed Linvatec | 06/26/2012Terminated |