Auxilock GFS Mini, GFS II Large, and GFS Ultimate
FDA 510(k) K213018 · Auxein Medical Private Limited
510(k) numberK213018
Submission
- Device name
- Auxilock GFS Mini, GFS II Large, and GFS Ultimate
- Applicant
- Auxein Medical Private Limited
Sonipat, IN - Received
- September 20, 2021
- Decision date
- November 18, 2022
- 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 |
|---|---|---|
| K221787 | Auxein's DHS/DCS Plate SystemKTT · Traditional | 11/30/2023SE |
| K213059 | Tibia and Fibula SystemHRS · Traditional | 01/27/2023SE |
| K213110 | AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorMBI · Traditional | 12/16/2022SE |
| K213108 | Humerus & Ulna SystemHRS · Traditional | 11/04/2022SE |
| K213014 | Varixis Elbow SystemHRS · Traditional | 10/03/2022SE |
| K213109 | Auxilock Draw Tight Suture-Based AnchorMBI · Traditional | 08/22/2022SE |
| K213104 | Auxilock Titanium Screw-In Suture AnchorMBI · Traditional | 07/29/2022SE |
| K211324 | 2.4mm Distal Radius SystemHRS · Traditional | 03/14/2022SE |
| K210792 | Auxein Nailing SystemHWC · Special | 08/25/2021SE |
| K203029 | Auxilock Titanium Interference ScrewHWC · Traditional | 08/20/2021SE |
Questions and answers
When was Auxilock GFS Mini, GFS II Large, and GFS Ultimate cleared by the FDA?
Auxilock GFS Mini, GFS II Large, and GFS Ultimate (K213018) received a 510(k) decision of Substantially Equivalent on November 18, 2022, 424 days after the submission was received.
What is the product code of K213018?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.