Iconix Speed Anchor; Iconix Speed HA+ Anchor
FDA 510(k) K252144 · Riverpoint Medical
510(k) numberK252144
Submission
- Device name
- Iconix Speed Anchor; Iconix Speed HA+ Anchor
- Applicant
- Riverpoint Medical
Portland, OR, US - Received
- July 8, 2025
- Decision date
- July 30, 2025
- 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 |
|---|---|---|
| K262677 | Iconix Knotless TMBI · Special | 08/27/2026SE |
| K253693 | Strut Suture; No-Tie ButtonMBI · Traditional | 03/11/2026SE |
| K253695 | LigaMendMBI · Traditional | 02/27/2026SE |
| K253024 | ProZip Knotless ImplantGAT · Special | 10/16/2025SE |
| K252201 | HS FiberGAT · Special | 08/13/2025SE |
| K243988 | RootMend MRRMBI · Traditional | 03/20/2025SE |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructMBI · Traditional | 11/26/2024SE |
| K243323 | Iconix Knotless AnchorMBI · Special | 11/19/2024SE |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorMBI · Special | 10/29/2024SE |
| K241282 | RibFix Titan Fixation SystemHRS · Traditional | 08/19/2024SE |
Questions and answers
When was Iconix Speed Anchor; Iconix Speed HA+ Anchor cleared by the FDA?
Iconix Speed Anchor; Iconix Speed HA+ Anchor (K252144) received a 510(k) decision of Substantially Equivalent on July 30, 2025, 22 days after the submission was received.
What is the product code of K252144?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.