# K130427: Pioneer Aspect Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Jun 5, 2013 after 105 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: 8 generations back to K922087 (1992). 33 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111528: Pioneer Aspect Anterior Cervical Plate Model 24-Series, Pioneer Surgical Technology, Inc. (2011) Summary page 2.
- K100708: Pioneer Anterior Cervical Plate Model 24-Series, Pioneer Surgical Technology (2010) Summary page 2.
- K083663: PACP, Pioneer Surgical Technology (2009) Summary page 2.
- K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1997) Summary page 2.
- K103491: Skyline Anterior Cervical Plate System, A Johnson & Johnson Company (2011) Summary page 2.
- K052552: Hybrid Anterior Cervical Plate System, Depuy Spine, Inc. (2005) Summary page 2.

## Most influential descendants
- K183060: CervAlign™ Anterior Cervical Plate System (2019), 2 descendants of its own
- K211408: CervAlign® Anterior Cervical Plate System (2021), 1 descendant of its own
- K133245: Genesys Spine Anterior Cervical Plate II System (2014), 1 descendant of its own
- K251436: Resolve Anterior Cervical Plate System (2025), 0 descendants of its own
- K192076: Binary® Anterior Cervical Plate System (2019), 0 descendants of its own

## Indications for use
The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K130427
Methodology: https://510kreport.com/methodology