# K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Jan 21, 2005 after 63 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: 5 generations back to K841189 (1984). 10 ancestors in all.
1,571 later devices descend from it; 12 cite it directly.
1 of 1,582 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042268: Ebi Cas Spine Spacer System, Ebi, L.P. (2004) Summary page 1.

## Most influential descendants
- K062759: Paramount VBR System (2007), 1,406 descendants of its own
- K072120: Paramount Intervertebral Body Fusion Device (2007), 1,405 descendants of its own
- K043479: MC+ Partial VBR (2005), 1,214 descendants of its own
- K073291: Capstone Spinal System (2008), 1,103 descendants of its own
- K100175: Clydesdale Spinal System (2010), 1,008 descendants of its own

## Indications for use
The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (TL-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 T1-5). The interior of the Pioneer Vertebral Spacer implant can be packed with bone.

Source page: https://510kreport.com/device/K043206
Methodology: https://510kreport.com/methodology