# K053053: Pacp System

- Pathway: 510(k) (Special)
- Applicant: Pioneer Surgical Technology
- Decided: Nov 16, 2005 after 16 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: 4 generations back to K922087 (1992). 22 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043066: Pioneer Anterior Cervical Plate System, Pioneer Surgical Technology (2005) Summary page 1.

## Most influential descendants
- 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
- K233640: Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System (2024), 5 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), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K053053
Methodology: https://510kreport.com/methodology