# K120724: Pioneer Lateral Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: May 7, 2012 after 59 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- 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: 3 generations back to K022791 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070273: Modification to Nuvasive Lateral Plate System, Nuvasive, Inc. (2007) Summary page 1.
- K090222: Pioneer Lumbar Plate System, Pioneer Surgical Technology (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K080815: Tosca II Anterior Cervical Plate System, Signus Medizintechnik GmbH (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Pioneer Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Source page: https://510kreport.com/device/K120724
Methodology: https://510kreport.com/methodology