FDA Product Code
FDA Product Code MBI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 604 records · page 1 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261869 | Integrity Retractable Implant Inserter (6000127) | Anika Therapeutics, Inc. | 2026-09-17 | Traditional | PDF ↗ |
| K253065 | Aevumed SUPERCYNCH Button System | Aevumed, Inc. | 2026-09-02 | Traditional | PDF ↗ |
| K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026-09-02 | Special | PDF ↗ |
| K262677 | Iconix Knotless T | Riverpoint Medical | 2026-08-27 | Special | PDF ↗ |
| K262047 | Grappler Suture Anchor System | Paragon 28, Inc. | 2026-08-03 | Special | PDF ↗ |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | Stryker Endoscopy | 2026-07-30 | Special | PDF ↗ |
| K261770 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2026-07-29 | Traditional | PDF ↗ |
| K261632 | Thunderbolt System | Responsive Arthroscopy, Inc. | 2026-07-20 | Special | PDF ↗ |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | Smith & Nephew, Inc. | 2026-07-09 | Special | PDF ↗ |
| K260018 | Arthrex FiberButton | Arthrex, Inc. | 2026-06-26 | Traditional | PDF ↗ |
| K253130 | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 | Traditional | PDF ↗ |
| K261363 | Y-Knotless Flex Anchors | CONMED Corporation | 2026-05-13 | Special | PDF ↗ |
| K253027 | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | 2026-05-06 | Traditional | PDF ↗ |
| K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026-05-01 | Traditional | PDF ↗ |
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | 2026-04-21 | Special | PDF ↗ |
| K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-20 | Special | PDF ↗ |
| K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026-03-17 | Traditional | PDF ↗ |
| K254176 | SINEFIX | BAAT Medical Products B.V. | 2026-03-16 | Special | PDF ↗ |
| K251750 | Trax EX Anchor | Trax Surgical, Inc. | 2026-03-12 | Traditional | PDF ↗ |
| K253693 | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | 2026-03-11 | Traditional | PDF ↗ |
| K260405 | FiberTape Button | Arthrex, Inc. | 2026-03-09 | Special | PDF ↗ |
| K253538 | TeKBrace Knotless Anchor | Theramicro | 2026-03-06 | Traditional | PDF ↗ |
| K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | 2026-03-04 | Traditional | PDF ↗ |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-02 | Traditional | PDF ↗ |
| K253695 | LigaMend | Riverpoint Medical, LLC | 2026-02-27 | Traditional | PDF ↗ |
| K253763 | Y-Knotless Flex Anchors | Conmed Corporation | 2026-01-29 | Special | PDF ↗ |
| K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | 2026-01-28 | Special | PDF ↗ |
| K253618 | QuadLock Fixation System | Abanza Tecnomed S.L | 2026-01-06 | Traditional | PDF ↗ |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Arthrex, Inc. | 2025-12-30 | Special | PDF ↗ |
| K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical | 2025-12-04 | Traditional | PDF ↗ |
| K252664 | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. | 2025-11-04 | Traditional | PDF ↗ |
| K252314 | Arthrex SutureTak Suture Anchor | Arthrex, Inc. | 2025-10-29 | Traditional | PDF ↗ |
| K253040 | Aevumed FASE Suture Anchor | Aevumed, Inc. | 2025-10-21 | Special | PDF ↗ |
| K253010 | Mini Superhawk Suture Anchor System | Responsive Arthroscopy, LLC | 2025-10-14 | Special | PDF ↗ |
| K250095 | All-Suture Dual Anchor System | Suturetech, Inc. | 2025-09-05 | Traditional | PDF ↗ |
| K242895 | Aevumed PHANTOM Suture Anchors | Aevumed, Inc. | 2025-08-06 | Traditional | PDF ↗ |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ Anchor | Riverpoint Medical | 2025-07-30 | Special | PDF ↗ |
| K251310 | OTS 25-L (100-5) | Ots Medical , Ltd. | 2025-07-22 | Traditional | PDF ↗ |
| K251809 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2025-07-18 | Traditional | PDF ↗ |
| K251145 | Arthrex PushLock Suture Anchors | Arthrex, Inc. | 2025-07-10 | Traditional | PDF ↗ |
| K251933 | SnugFit ASA Extension | Medacta International S.A. | 2025-07-01 | Special | PDF ↗ |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | Smith & Nephew, Inc. | 2025-06-25 | Special | PDF ↗ |
| K251530 | CONMED Argo Knotless® Anchor | Conmed Corporation | 2025-06-18 | Special | PDF ↗ |
| 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 | 2025-06-02 | Traditional | PDF ↗ |
| K242477 | Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty, Ltd. | 2025-05-12 | Traditional | PDF ↗ |
| K250596 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2025-03-28 | Special | PDF ↗ |
| K243988 | RootMend MRR | Riverpoint Medical, LLC | 2025-03-20 | Traditional | PDF ↗ |
| K250424 | Arthrex TightRope Soft Button, RT | Arthrex, Inc. | 2025-03-11 | Special | PDF ↗ |
| K250238 | WasherCap Fixation System | Abanza Tecnomed S.L | 2025-02-25 | Special | PDF ↗ |
| K244015 | SuperBall-RC | Arcuro Medical , Ltd. | 2025-02-19 | Traditional | PDF ↗ |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) | ZheJiang Decans Medical Devices Co., Ltd. | 2025-01-31 | Traditional | PDF ↗ |
| K243712 | WasherCap Mini Fixation System (Model 45) | Abanza Tecnomed S.L | 2025-01-30 | Traditional | PDF ↗ |
| K243726 | Osprey Suture Anchor | Responsive Arthroscopy, Inc. | 2025-01-30 | Traditional | PDF ↗ |
| K244025 | Argo Knotless GENESYS Anchor | Conmed Corporation | 2025-01-28 | Special | PDF ↗ |
| K241234 | OTS 25-L (100-5) | Ots Medical , Ltd. | 2025-01-23 | Traditional | PDF ↗ |
| K242529 | Tigon Medical All-Suture Anchors (ASA) | Tigon Medical | 2024-12-20 | Traditional | PDF ↗ |
| K243470 | Fix2Lock (PEEK Self Punching) | Osteonic Co., Ltd. | 2024-12-03 | Special | PDF ↗ |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct | Riverpoint Medical, LLC | 2024-11-26 | Traditional | PDF ↗ |
| K243323 | Iconix Knotless Anchor | Riverpoint Medical | 2024-11-19 | Special | PDF ↗ |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor | Riverpoint Medical | 2024-10-29 | Special | PDF ↗ |
| K241695 | Extremity All Suture System | Field Orthopaedics | 2024-09-12 | Traditional | PDF ↗ |
| K242296 | VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK) | Ortho-Design (Pty), Ltd. | 2024-08-29 | Special | PDF ↗ |
| K233601 | Fixone Meniscal Repair | Aju Pharm Co., Ltd. | 2024-08-02 | Traditional | PDF ↗ |
| K241864 | Grappler Interference Screw System | Paragon 28, Inc. | 2024-07-25 | Special | PDF ↗ |
| K240835 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2024-07-19 | Traditional | PDF ↗ |
| K241577 | Iconix® Anchor | Riverpoint Medical | 2024-07-03 | Special | PDF ↗ |
| K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue | Smith & Nephew, Inc. | 2024-06-20 | Special | PDF ↗ |
| K241235 | Arthrex TightRope II | Arthrex, Inc. | 2024-05-29 | Special | PDF ↗ |
| K232941 | Megaloop Button System | Suzhou Endophix Co., Ltd. | 2024-05-03 | Traditional | PDF ↗ |
| K240719 | OC JuggerKnot Soft Anchor | Riverpoint Medical | 2024-04-11 | Special | PDF ↗ |
| K240594 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2024-03-26 | Special | PDF ↗ |
| K240407 | ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor | Stryker Endoscopy | 2024-03-07 | Special | PDF ↗ |
| K240213 | Iconix Knotless Anchor | Riverpoint Medical | 2024-02-23 | Special | PDF ↗ |
| K240194 | ProCinch, QuadCinch | Riverpoint Medical | 2024-02-21 | Special | PDF ↗ |
| K233893 | AlphaVent Knotless SP PEEK Anchor | Stryker Endoscopy | 2024-01-25 | Traditional | PDF ↗ |
| K233730 | Footprint Mini PK, 3.5mm Suture Anchor | Smith & Nephew | 2024-01-17 | Traditional | PDF ↗ |
| K231033 | CEPTRE® Knotted UHMWPE Suture PEEK Anchor | Healthium Medtech Limited | 2024-01-04 | Traditional | PDF ↗ |
| K230891 | SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant | Healthium Medtech Limited | 2023-12-28 | Traditional | PDF ↗ |
| K233659 | Suture Wing | Osteonic Co., Ltd. | 2023-12-26 | Special | PDF ↗ |
| K233429 | OTS 25 (100-1) | Ots Medical , Ltd. | 2023-12-07 | Traditional | PDF ↗ |
| K233552 | IDEAL Ziploop | Riverpoint Medical | 2023-11-30 | Special | PDF ↗ |
| K232973 | Arthrex Knee FiberTak® Button Suture Anchor | Arthrex, Inc. | 2023-11-15 | Traditional | PDF ↗ |
| K233468 | Iconix Anchor | Riverpoint Medical | 2023-11-14 | Special | PDF ↗ |
| K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | Healthium Medtech Limited | 2023-11-08 | Traditional | PDF ↗ |
| K232742 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2023-11-03 | Traditional | PDF ↗ |
| K232725 | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | Suzhou Endophix Co., Ltd. | 2023-11-02 | Traditional | PDF ↗ |
| K232683 | Knotilus+ PEEK Knotless Anchor | Stryker Endoscopy | 2023-10-24 | Traditional | PDF ↗ |
| K233258 | Shadow Knotless All-Suture Anchors | Responsive Arthroscopy, LLC | 2023-10-23 | Special | PDF ↗ |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | Medos International SARL | 2023-10-06 | Traditional | PDF ↗ |
| K232411 | JuggerKnot Soft Anchor OC | Riverpoint Medical, LLC | 2023-10-06 | Traditional | PDF ↗ |
| K231078 | All-Suture Anchor | Riverpoint Medical, LLC | 2023-10-05 | Traditional | PDF ↗ |
| K232592 | CITRELOCK® DUO | Acuitive Technologies, Inc. | 2023-09-20 | Special | PDF ↗ |
| K230517 | Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) | Jarmon Medical, LLC (Dba Legends Orthopedics) | 2023-09-11 | Traditional | PDF ↗ |
| K232457 | Q-FIX ULTRA All-Suture Anchor | Smith & Nephew | 2023-09-08 | Special | PDF ↗ |
| K232340 | Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor | Arthrex, Inc. | 2023-09-01 | Special | PDF ↗ |
| K231093 | AlphaVent Suture Anchors | Stryker Endoscopy | 2023-08-30 | Traditional | PDF ↗ |
| K230094 | Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors | Responsive Arthroscopy, LLC | 2023-08-25 | Traditional | PDF ↗ |
| K231867 | Grappler Suture Anchor System | Paragon 28, Inc. | 2023-08-21 | Traditional | PDF ↗ |
| K231376 | Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) | Smith & Nephew, Inc. | 2023-08-09 | Traditional | PDF ↗ |
| K231857 | Arthrex TightRope II | Arthrex, Inc. | 2023-08-08 | Traditional | PDF ↗ |
Product code MBI · Class II · Orthopedic. Data: openFDA.