# K161680: MEDICON Spinal Spreading Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medicon EG
- Decided: Mar 24, 2017 after 280 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: 4 generations back to K992898 (1999). 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)
- K161004: Self-retaining Retractor, Fetzer Medical GmbH & Co. KG (2016). Cleared while this submission was under review Summary page 4.
- K964402: Versatrac (TM) Lumbar Retractor System, V. Mueller Neuro/Spine (1997) Summary page 4.
- K935529: Cervical Self-Retaining Retractor, T. Korossurgical Instruments Corp. (1994) Summary page 4.

## Indications for use
The MEDICON Spinal Spreading Systems are used to spread soft tissue and maintain surgical access in spine surgery and may only be used by surgeons with proper training and adequate experience in spine surgery.

Source page: https://510kreport.com/device/K161680
Methodology: https://510kreport.com/methodology