# K113273: Spotlight Access System

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson
- Decided: Jan 27, 2012 after 81 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 K002931 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K043602: Quadrant Retractor System, Medtronic Sofamor Danek (2005) Summary page 1.
- K964402: Versatrac (TM) Lumbar Retractor System, V. Mueller Neuro/Spine (1997) Summary page 2.

## Indications for use
The SPOTLIGHTr' Access System and SPOTLIGH~rM PL, are intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port or retractor, down to the posterior and posterolaferal bony spinal elements. These ports and retractors 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/K113273
Methodology: https://510kreport.com/methodology