# K043066: Pioneer Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Feb 3, 2005 after 87 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 K922087 (1992). 21 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1997) Summary page 1.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 1.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K040261: Reflex Hybrid Anterior Cervical Plate System, Stryker Spine (2004) Summary page 1.
- K971730: Depuy Motech Peak Polyaxial Anterior Cervical Plate System, Depuy, Inc. (1997) Summary page 1.
- K982443: Doc Ventral Cervical Stabilization System, Depuy Motech Acromed (1998) Summary page 1.
- K040655: Swift Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 1.
- K000486: Abc Cervical Plating System, Aesculap, Inc. (2000) Summary page 1.

## Most influential descendants
- K053053: Pacp System (2005), 25 descendants of its own
- K072703: Pioneer Slimfuse Anterior Cervical Plating System (2008), 19 descendants of its own
- K083663: PACP (2009), 17 descendants of its own
- K100708: Pioneer Anterior Cervical Plate Model 24-Series (2010), 12 descendants of its own
- K111528: Pioneer Aspect Anterior Cervical Plate Model 24-Series (2011), 11 descendants of its own

## Indications for use
The Pioneer Anterior Cervical Plate System is intended for anterior cervical fixation 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), tunmor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K043066
Methodology: https://510kreport.com/methodology