Tigon Medical Button System
FDA 510(k) K211049 · Tigon Medical
510(k) numberK211049
Submission
- Device name
- Tigon Medical Button System
- Applicant
- Tigon Medical
Severna Park, MD, US - Received
- April 8, 2021
- Decision date
- August 4, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBI
| 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 |
More from ZheJiang Decans Medical Devices Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineMBI · Special | 04/21/2026SE |
| K252596 | Tigon Medical Knotless and Dual Javelin All-Suture AnchorsMBI · Traditional | 12/04/2025SE |
| K242529 | Tigon Medical All-Suture Anchors (ASA)MBI · Traditional | 12/20/2024SE |
| K240175 | Tigon Medical Fractures, Instability, and Reconstruction (FIRE)HWC · Traditional | 10/29/2024SE |
| K220464 | Tigon Medical Gryphon Anchor LineMBI · Traditional | 03/22/2023SE |
| K182507 | Tigon Medical Tissue AnchorsMBI · Traditional | 01/21/2019SE |
Questions and answers
When was Tigon Medical Button System cleared by the FDA?
Tigon Medical Button System (K211049) received a 510(k) decision of Substantially Equivalent on August 4, 2021, 118 days after the submission was received.
What is the product code of K211049?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.