# K062814: Pipeline II Access System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: Dec 15, 2006 after 86 days
- Product code: GZT (Retractor, Self-Retaining, For Neurosurgery)
- Device class: 2
- Regulation: 21 CFR 882.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992898 (1999). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992898: The Bright Medical Dilation Retractor System, Bright Medical Instruments (1999) Summary page 1.

## Most influential descendants
- K113273: Spotlight Access System (2012), 0 descendants of its own
- K112913: Spotlight Access System (2011), 0 descendants of its own

## Indications for use
The PIPELINE Access System is intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port, down to the lamina, with its attachment to a rigid arm to provide a self-locking method of access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.

Source page: https://510kreport.com/device/K062814
Methodology: https://510kreport.com/methodology