Dunamis PunchTac Suture Anchors
FDA 510(k) K193245 · Dunamis, LLC
510(k) numberK193245
Submission
- Device name
- Dunamis PunchTac Suture Anchors
- Applicant
- Dunamis, LLC
Greenville, AL, US - Received
- November 25, 2019
- Decision date
- February 14, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K191319 | Dunamis Fixation Button SystemMBI · Traditional | 08/29/2019SE |
| K160996 | Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmMBI · Traditional | 07/06/2016SE |
| K153746 | Dunamis Force DFX Tensile TapeGAT · Traditional | 03/03/2016SE |
| K151220 | Dunamis Interference ScrewMBI · Traditional | 10/14/2015SE |
| K150327 | Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2GAT · Traditional | 06/29/2015SE |
Questions and answers
When was Dunamis PunchTac Suture Anchors cleared by the FDA?
Dunamis PunchTac Suture Anchors (K193245) received a 510(k) decision of Substantially Equivalent on February 14, 2020, 81 days after the submission was received.
What is the product code of K193245?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.