Fixone All Suture Anchor
FDA 510(k) K192709 · Aju Pharm Co., Ltd.
510(k) numberK192709
Submission
- Device name
- Fixone All Suture Anchor
- Applicant
- Aju Pharm Co., Ltd.
Seongnam-Si, KR - Received
- September 27, 2019
- Decision date
- December 15, 2020
- 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 |
|---|---|---|
| K233601 | Fixone Meniscal RepairMBI · Traditional | 08/02/2024SE |
| K230892 | Fixone Biocomposite AnchorMAI · Special | 06/09/2023SE |
| K222423 | Fixone All Suture AnchorMBI · Special | 03/23/2023SE |
| K203523 | Fixone hybrid knotless anchorMAI · Traditional | 12/25/2021SE |
| K193497 | Fixone Biocomposite Interference ScrewHWC · Traditional | 01/05/2021SE |
| K192484 | Fixone Biocomposite AnchorMAI · Special | 03/11/2020SE |
| K192032 | Fixone Biocomposite Small AnchorMAI · Traditional | 03/03/2020SE |
| K171299 | Fixone Biocomposite AnchorMAI · Traditional | 08/24/2017SE |
| K162070 | Joinix Cannular SystemHRX · Traditional | 03/16/2017SE |
Questions and answers
When was Fixone All Suture Anchor cleared by the FDA?
Fixone All Suture Anchor (K192709) received a 510(k) decision of Substantially Equivalent on December 15, 2020, 445 days after the submission was received.
What is the product code of K192709?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.