# K150254: Streamline OCT Occipito-Cervico-Thoracic System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
- Decided: Apr 28, 2015 after 84 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K003155 (2001). 122 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133374: Streamline Oct Occipito-Cervico-Thoracic System, Pioneer Surgical Technology, Inc. (Rti Surgical, I (2014) Summary page 4.
- K132332: Mountaineer Oct Spinal System, Medos International SARL (2013) Summary page 4.
- K133556: Virage Oct Spinal Fixation System, Zimmer Spine, Inc. (2014) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Sep 16, 2016 · Class II · Z-0290-2017: RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline OCT Straight Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small cracks to be present on the
- Apr 22, 2016 · Class II · Z-1829-2016: Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possi
- Mar 18, 2016 · Class II · Z-1393-2016: Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic 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 (T1-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 (C1-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/K150254
Methodology: https://510kreport.com/methodology