# K133374: Streamline Oct Occipito-Cervico-Thoracic System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc. (Rti Surgical, I
- Decided: Mar 19, 2014 after 138 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: 15 generations back to K003155 (2001). 115 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121725: Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System, Pioneer Surgical Technology, Inc. (2012) Summary page 1.
- K110197: Exactech Gibralt Spinal System, Exactech, Inc. (2011)
- K121877: Gibralt  Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital Plates, Exactech, Inc. (2013) Summary page 1.
- K991089: Synthes Cervifix System, Synthes Spine (1999) Summary page 1.
- K023675: Synthes Cervifix/ Axon, Synthes (Usa) (2002) Summary page 1.
- K031985: Spinal Concepts Inc. Nex-Link Spinal Fixation System, Spinal Concepts, Inc. (2003) Summary page 1.
- K110353: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2011)
- K093319: Nuvasive Vuepoint Oct System, Nuvasive, Inc. (2010) Summary page 1.

## Most influential descendants
- K150254: Streamline OCT Occipito-Cervico-Thoracic System (2015), 2 descendants of its own
- K161498: Streamline OCT Occipito-Cervico-Thoracic System (2016), 1 descendant of its own
- K172139: Streamline OCT Occipito-Cervico-Thoracic System (2017), 0 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico thoracic junction (occiput-T3); the Streamline 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 Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.

Source page: https://510kreport.com/device/K133374
Methodology: https://510kreport.com/methodology