# K101525: Pioneer Spinous Process Fusion Plate

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Oct 22, 2010 after 142 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K110367: Pioneer Spinal Process Fusion Plate (2011), 0 descendants of its own

## Indications for use
The Pioneer Spinous Process Fusion Plate is a posterior, non-pedlicle supplemental fixation device, intended for use at a single level in the non-cervical spine (Ti-Si). 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 discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma (i.e., fracture or dislocation); and/or tumor. The Pioneer SPFP is intended for use with bone graft material (i.e. allograph or autograph), not intended for stand-alone use.

Source page: https://510kreport.com/device/K101525
Methodology: https://510kreport.com/methodology