Product code MBI
- Device name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3040
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260018 | Arthrex FiberButton | Arthrex, Inc. | 2026-06-26 |
| K253130 | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 |
| K261363 | Y-Knotless™ Flex Anchors | CONMED Corporation | 2026-05-13 |
| K253027 | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | 2026-05-06 |
| K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026-05-01 |
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | 2026-04-21 |
| K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-20 |
| K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026-03-17 |
| K254176 | SINEFIX | BAAT Medical Products B.V. | 2026-03-16 |
| K251750 | Trax EX Anchor | Trax Surgical, Inc. | 2026-03-12 |
| K253693 | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | 2026-03-11 |
| K260405 | FiberTape Button | Arthrex, Inc. | 2026-03-09 |
| K253538 | TeKBrace Knotless Anchor | Theramicro | 2026-03-06 |
| K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | 2026-03-04 |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-02 |
| K253695 | LigaMend | Riverpoint Medical, LLC | 2026-02-27 |
| K253763 | Y-Knotless™ Flex Anchors | Conmed Corporation | 2026-01-29 |
| K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | 2026-01-28 |
| K253618 | QuadLock™ Fixation System | Abanza Tecnomed S.L | 2026-01-06 |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Arthrex, Inc. | 2025-12-30 |
| K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical | 2025-12-04 |
| K252664 | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. | 2025-11-04 |
| K252314 | Arthrex SutureTak Suture Anchor | Arthrex, Inc. | 2025-10-29 |
| K253040 | Aevumed FASE Suture Anchor | Aevumed, Inc. | 2025-10-21 |
| K253010 | Mini Superhawk Suture Anchor System | Responsive Arthroscopy, LLC | 2025-10-14 |
| K250095 | All-Suture Dual Anchor System | Suturetech, Inc. | 2025-09-05 |
| K242895 | Aevumed PHANTOM Suture Anchors | Aevumed, Inc. | 2025-08-06 |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ Anchor | Riverpoint Medical | 2025-07-30 |
| K251310 | OTS 25-L (100-5) | Ots Medical , Ltd. | 2025-07-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810155331412 | Tigon Medical | Tigon Medical LLC | 2026-07-09 |
| 00850029805106 | Tigon Medical | Tigon Medical LLC | 2026-06-26 |
| 09353903030201 | Griplasty System | FIELD ORTHOPAEDICS PTY LTD | 2026-06-24 |
| 00888867465237 | Arthrex® | ARTHREX, INC. | 2025-06-23 |
| 00888867465244 | Arthrex® | ARTHREX, INC. | 2025-06-23 |
| 00888867501324 | Arthrex® | ARTHREX, INC. | 2025-06-23 |
| 00888867501331 | Arthrex® | ARTHREX, INC. | 2025-06-23 |
| 00888867465220 | Arthrex® | ARTHREX, INC. | 2025-06-23 |
| 00888867023345 | Arthrex® | ARTHREX, INC. | 2018-08-31 |
| 00888867023154 | Arthrex® | ARTHREX, INC. | 2018-08-31 |
| 00888867022980 | Arthrex® | ARTHREX, INC. | 2018-08-31 |
| 00888867022966 | Arthrex® | ARTHREX, INC. | 2018-08-31 |
| 00888867023925 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867019676 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00841132135266 | ACL Reconstruction | ORTHOPEDIATRICS CORP. | 2017-02-15 |
| 00841132122181 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122198 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122204 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122211 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122228 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122235 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122242 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122174 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122167 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122150 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122143 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122136 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122129 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 00841132122112 | OrthoPediatrics ACL Reconstruction System | ORTHOPEDIATRICS CORP. | 2015-09-18 |
| 10886705001309 | RIGIDFIX BIOCRYL | Medos International Sàrl | 2015-09-01 |