# K161004: Self-retaining Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Fetzer Medical GmbH & Co. KG
- Decided: Sep 9, 2016 after 151 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: 3 generations back to K992898 (1999). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071771: Instrumed Retractors, Instrumed International, Inc. (2007) Summary page 4.
- K964402: Versatrac (TM) Lumbar Retractor System, V. Mueller Neuro/Spine (1997) Summary page 4.

## Most influential descendants
- K161680: MEDICON Spinal Spreading Systems (2017), 0 descendants of its own

## Indications for use
Fetzer Medical Self-Retaining Retractors are intended to hold the edges of a wound open during spinal surgery.

Source page: https://510kreport.com/device/K161004
Methodology: https://510kreport.com/methodology