# K131724: Pioneer Maxfuse Vertebral Body Replacement Device

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Dec 24, 2013 after 195 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K841189 (1984). 20 ancestors in all.
73 later devices descend from it; 2 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061151: Pioneer Vertebral Spacer (Vertebral Spacer), Pioneer Surgical Technology (2006) Summary page 1.
- K073649: Bengal Stackable Cage System, Depuy Spine, Inc. (2008) Summary page 1.
- K032476: Nuvasive Mesh, Nuvasive, Inc. (2003) Summary page 1.

## Most influential descendants
- K142030: STGC-Lordotic (2015), 58 descendants of its own
- K152568: C-VBR (2016), 57 descendants of its own
- K162315: FORTIFY Corpectomy Spacers (2017), 55 descendants of its own
- K181328: T2 STRATOSPHERE™ Expandable Corpectomy System (2018), 28 descendants of its own
- K183510: T2 STRATOSPHERE Expandable Corpectomy System (2019), 27 descendants of its own

## Indications for use
The MaxFuse VBR System is indicated for use in the thoracolumbar spine (i.e., TI-LS) to replace a diseased vertebral body resected or excised for the treatment of tumors. to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The MaxF *useVBR System is also indicated for treating fractures of the thomacic and lumbar spine. The MaxFuse VBR System isdesigned to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of futsion for a prolonged period. The MaxFuse VBR System is intended for use with supplemental internal fixation systems cleared for the conditions listed above. The supplemental internal fixation systems that may be used include the Quantum Spinal Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS Spinal Fixation System.

Source page: https://510kreport.com/device/K131724
Methodology: https://510kreport.com/methodology