# K112757: Pioneer Posterior Cervico Thoracic System

- Pathway: 510(k) (Special)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Mar 12, 2012 after 172 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K853033 (1985). 13 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092295: Pioneer Posterior Cervico-Thoracic System, Pioneer Surgical Technology (2010) Summary page 2.

## Most influential descendants
- K121725: Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System (2012), 17 descendants of its own
- K171369: M.U.S.T. MINI Posterior Cervical Screws System (2017), 8 descendants of its own
- K200130: M.U.S.T. MINI Posterior Cervical Screws System (2020), 6 descendants of its own
- K200936: Invictus™ CT Spinal Fixation System (2020), 3 descendants of its own
- K133374: Streamline Oct Occipito-Cervico-Thoracic System (2014), 3 descendants of its own

## Recalls of this device
- Sep 10, 2012 · Class II · Z-2573-2014: Some set screw thread profiles were found not to be within specifications.

## Indications for use
The Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1-13). The intended indications are as follows: - Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - Spondylolisthesis - Spinal Stenosis - Fracture/ Dislocation - Deformities or Curvature - Tumors - Pseudoarthrosis - Revision of previous cervical and upper thoracic spine surgery The use of the screws is limited to placement in the upper thoracic spine (T I-T3) in treating thoracic conditions only. Thie screws are not intended for use in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture! dislocation or trauma in the cervical! upper thoracic (CI -T3) spine.

Source page: https://510kreport.com/device/K112757
Methodology: https://510kreport.com/methodology