Vertiwedge® Intraosseous System
FDA 510(k) K261810 · Foundation Surgical Group
510(k) numberK261810
Submission
- Device name
- Vertiwedge® Intraosseous System
- Applicant
- Foundation Surgical Group
Scottsdale, AZ, US - Received
- June 1, 2026
- Decision date
- July 31, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
| K200235 | KONG-TL VBR System, KONG-C VBR SystemMQP · Traditional | Icotec AG | 05/29/2020SE |
More from Icotec AG
| 510(k) | Device | Decision |
|---|---|---|
| K261809 | Interwedge® Standalone LateralOVD · Special | 07/31/2026SE |
| K260011 | Foundation Surgical Navigated Lateral Disc Prep InstrumentsOLO · Traditional | 04/16/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | 11/07/2024SE |
| K241487 | Interwedge® Standalone LateralOVD · Traditional | 10/02/2024SE |
Questions and answers
When was Vertiwedge® Intraosseous System cleared by the FDA?
Vertiwedge® Intraosseous System (K261810) received a 510(k) decision of Substantially Equivalent on July 31, 2026, 60 days after the submission was received.
What is the product code of K261810?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.