# K090222: Pioneer Lumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Apr 28, 2009 after 88 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: 2 generations back to K022791 (2002). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063158: Synthes Antegra System, Synthes Spine Co.Lp (2006) Summary page 1.
- K041167: Pioneer Surgical Technology Quantum Spinal System, Pioneer Surgical Technology (2004) Summary page 1.

## Most influential descendants
- K182808: Aspida® Anterior Lumbar Plating System (2018), 1 descendant of its own
- K230721: ATEC Lateral Plate System (2023), 0 descendants of its own
- K120724: Pioneer Lateral Plate System (2012), 0 descendants of its own

## Indications for use
The Pioneer Lumbar Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The Pioneer Lumbar Plate System is indicated as an adjunct to fusion in the treatment of lumbar and lumbosacral (LI -SI) spine instability as a result of the following: 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), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, and failed previous spine surgery. Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K090222
Methodology: https://510kreport.com/methodology