Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
FDA 510(k) K230094 · Responsive Arthroscopy, LLC
510(k) numberK230094
Submission
- Device name
- Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
- Applicant
- Responsive Arthroscopy, LLC
Minneapolis, MN, US - Received
- January 12, 2023
- Decision date
- August 25, 2023
- 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 |
|---|---|---|
| K261632 | Thunderbolt SystemMBI · Special | 07/20/2026SE |
| K253010 | Mini Superhawk Suture Anchor SystemMBI · Special | 10/14/2025SE |
| K243726 | Osprey Suture AnchorMBI · Traditional | 01/30/2025SE |
| K233258 | Shadow Knotless All-Suture AnchorsMBI · Special | 10/23/2023SE |
| K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsMBI · Special | 10/13/2022SE |
| K203121 | Responsive Arthroscopy Thunderbolt SystemMBI · Traditional | 04/27/2021SE |
| K202569 | Responsive Arthroscopy Interference Screw SystemHWC · Special | 09/23/2020SE |
| K202153 | Responsive Arthroscopy Suture Anchor SystemMBI · Special | 09/09/2020SE |
| K190446 | Responsive Arthroscopy Wedge Push-In Suture AnchorsMBI · Special | 03/27/2019SE |
| K181076 | Responsive Arthroscopy Wedge Push-In Suture AnchorsMBI · Traditional | 01/18/2019SE |
Questions and answers
When was Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors cleared by the FDA?
Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors (K230094) received a 510(k) decision of Substantially Equivalent on August 25, 2023, 225 days after the submission was received.
What is the product code of K230094?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.