# K071771: Instrumed Retractors

- Pathway: 510(k) (Abbreviated)
- Applicant: Instrumed International, Inc.
- Decided: Aug 2, 2007 after 34 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). 4 ancestors in all.
2 later devices descend 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)
- K050706: Harmony Port System, Model 1907 Series, Spinal Concepts, Inc. (2005) Summary page 1.
- K992898: The Bright Medical Dilation Retractor System, Bright Medical Instruments (1999) Summary page 1.
- K935529: Cervical Self-Retaining Retractor, T. Korossurgical Instruments Corp. (1994) Summary page 1.
- K964402: Versatrac (TM) Lumbar Retractor System, V. Mueller Neuro/Spine (1997) Summary page 1.

## Most influential descendants
- K161004: Self-retaining Retractor (2016), 1 descendant of its own
- K161680: MEDICON Spinal Spreading Systems (2017), 0 descendants of its own

## Indications for use
INSTRUMED retractors are devices intended to provide minimally invasive access to the spine by ensuring the placement, positioning of the retractor down to the lamina, with its attachment to a flexible arm to provide a self locking method of access to the spinal site through which tubes, microscopes and surgical instruments can be manipulated.

Source page: https://510kreport.com/device/K071771
Methodology: https://510kreport.com/methodology