# K061151: Pioneer Vertebral Spacer (Vertebral Spacer)

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Jul 24, 2006 after 90 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: 6 generations back to K841189 (1984). 11 ancestors in all.
801 later devices descend from it; 8 cite it directly.
1 of 813 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer), Pioneer Surgical Technology (2005) Summary page 1.

## Most influential descendants
- K073177: Pioneer Intervertebral Fusion Device System (2008), 775 descendants of its own
- K112496: Pioneer Crossfuse II Ibf/VBR System (2011), 604 descendants of its own
- K133623: C-PLUS (2014), 598 descendants of its own
- K133455: Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic (2014), 596 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own

## Indications for use
The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, the Pioneer Vertebral Spacer implant is intended to be used with bone graft.

Source page: https://510kreport.com/device/K061151
Methodology: https://510kreport.com/methodology