SUTUREFIX Curved Suture Anchor
FDA 510(k) K163034 · Smith and Nephew, Inc.
510(k) numberK163034
Submission
- Device name
- SUTUREFIX Curved Suture Anchor
- Applicant
- Smith and Nephew, Inc.
Andover, MA, US - Received
- October 31, 2016
- Decision date
- December 7, 2016
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K222501 | Regeneten Bioinductive ImplantOWY · Traditional | 05/11/2023SE |
| K221740 | Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith &…GCJ · Traditional | 10/20/2022SE |
| K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…GCJ · Traditional | 08/23/2019SE |
| K183232 | Double ENDOBUTTON Fixation DeviceHTN · Traditional | 03/12/2019SE |
| K181746 | MICRORAPTOR Knotless Suture AnchorMAI · Traditional | 09/28/2018SE |
| K180361 | MICRORAPTOR REGENESORB Suture AnchorMAI · Traditional | 05/30/2018SE |
Questions and answers
When was SUTUREFIX Curved Suture Anchor cleared by the FDA?
SUTUREFIX Curved Suture Anchor (K163034) received a 510(k) decision of Substantially Equivalent on December 7, 2016, 37 days after the submission was received.
What is the product code of K163034?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.