Pioneer Maxfuse Vertebral Body Replacement Device
FDA 510(k) K131724 · Pioneer Surgical Technology, Inc.
510(k) numberK131724
Submission
- Device name
- Pioneer Maxfuse Vertebral Body Replacement Device
- Applicant
- Pioneer Surgical Technology, Inc.
Marquette, MI, US - Received
- June 12, 2013
- Decision date
- December 24, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| 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 |
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| K222493 | CODA Anterior Cervical Plate SystemKWQ · Traditional | 11/18/2022SE |
| K211408 | CervAlign® Anterior Cervical Plate SystemKWQ · Traditional | 06/23/2021SE |
| K192396 | Streamline MIS Spinal Fixation SystemNKB · Traditional | 11/26/2019SE |
| K140696 | Streamline TL Spinal Fixation SystemNKB · Special | 04/10/2014SE |
| K133455 | Crossfuse II Coronal Taper, Crossfuse II HyperlordoticMAX · Traditional | 03/27/2014SE |
| K133623 | C-PlusODP · Traditional | 02/10/2014SE |
| K132050 | NB3D Bone Void FillerMQV · Traditional | 02/07/2014SE |
| K133785 | Tritium Sternal Cable Plate SystemJDQ · Traditional | 01/27/2014SE |
Questions and answers
When was Pioneer Maxfuse Vertebral Body Replacement Device cleared by the FDA?
Pioneer Maxfuse Vertebral Body Replacement Device (K131724) received a 510(k) decision of Substantially Equivalent on December 24, 2013, 195 days after the submission was received.
What is the product code of K131724?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.