# K110367: Pioneer Spinal Process Fusion Plate

- Pathway: 510(k) (Special)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Mar 23, 2011 after 43 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K101525 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101525: Pioneer Spinous Process Fusion Plate, Pioneer Surgical Technology (2010) Summary page 1.

## Indications for use
The Pioneer BacFuse Device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Pioneer BacFuse Device is intended for use with bone graft material (i.e. allograft or autograft), not intended for stand-alone use.

Source page: https://510kreport.com/device/K110367
Methodology: https://510kreport.com/methodology