# K121725: Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Nov 7, 2012 after 148 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K003155 (2001). 104 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112757: Pioneer Posterior Cervico Thoracic System, Pioneer Surgical Technology, Inc. (2012) Summary page 1.
- K113593: Nextgen Altius Oct System, Biomet Spine (Aka Ebi, LLC) (2012) Summary page 1.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 1.
- K100147: S4 Cervical Occipital Plate Spinal System, Aesculap Implant System, Inc. (2010) Summary page 1.

## Most influential descendants
- 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
- K150254: Streamline OCT Occipito-Cervico-Thoracic System (2015), 2 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System is intended for: 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, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, 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. The Pioneer Posterior OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System or Streamline TL Spinal System) using connectors.

Source page: https://510kreport.com/device/K121725
Methodology: https://510kreport.com/methodology