Aevumed PHANTOM Suture Anchors
FDA 510(k) K242895 · Aevumed, Inc.
510(k) numberK242895
Submission
- Device name
- Aevumed PHANTOM Suture Anchors
- Applicant
- Aevumed, Inc.
Malvern, PA, US - Received
- September 23, 2024
- Decision date
- August 6, 2025
- 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 |
|---|---|---|
| K253065 | Aevumed SUPERCYNCH Button SystemMBI · Traditional | 09/02/2026SE |
| K254306 | Aevumed FENIX Suture AnchorMBI · Traditional | 03/04/2026SE |
| K260004 | Aevumed PROTEKT Suture AnchorMBI · Special | 01/28/2026SE |
| K253040 | Aevumed FASE Suture AnchorMBI · Special | 10/21/2025SE |
| K223878 | Aevumed RAPID Suture AnchorsMBI · Traditional | 03/17/2023SE |
| K222363 | Aevumed PHANTOM-LP Suture AnchorsMBI · Traditional | 11/28/2022SE |
| K180464 | AEVUMED PHANTOM Suture AnchorsMBI · Traditional | 05/31/2018SE |
Questions and answers
When was Aevumed PHANTOM Suture Anchors cleared by the FDA?
Aevumed PHANTOM Suture Anchors (K242895) received a 510(k) decision of Substantially Equivalent on August 6, 2025, 317 days after the submission was received.
What is the product code of K242895?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.