# K112913: Spotlight Access System

- Pathway: 510(k) (Special)
- Applicant: Johnson & Johnson
- Decided: Dec 16, 2011 after 74 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: 2 generations back to K992898 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062814: Pipeline II Access System, Depuy Spine, Inc. (2006) Summary page 1.
- K992898: The Bright Medical Dilation Retractor System, Bright Medical Instruments (1999) Summary page 1.

## Indications for use
The SPOTLIGHT 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 posterior and posterolateral bony spinal elements. These ports provide 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/K112913
Methodology: https://510kreport.com/methodology