# K043602: Quadrant Retractor System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Feb 23, 2005 after 56 days
- Product code: GAD (Retractor)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002931 (2000). 2 ancestors in all.
29 later devices descend from it; 5 cite it directly.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002931: Metrx System, Medtronic Sofamor Danek, Inc. (2000) Summary page 2.
- K040483: Equestra Fluid Delivery System, Medtronic Sofamor Danek, Inc. (2004) Summary page 2.

## Most influential descendants
- K062038: X-Sten Mild Tool Kit, Model MTK-0001 (2006), 14 descendants of its own
- K093062: Vertos Medical Mild Device Kit (2010), 13 descendants of its own
- K060973: Vycor Surgical Access Systems (2006), 10 descendants of its own
- K120691: Brain Port (2012), 8 descendants of its own
- K180876: DTRAX Spinal System (2018), 7 descendants of its own

## Indications for use
The MAST QUADRANT TM Retractor System is intended to provide surgeons with instruments such as dilators, retractors, light sources and pedicle access needles used to perform a variett of spinal fixation procedures utilizing a minimally invasive approach. The MAST QUADRANT TM Retractor System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the MAST QUADRANTTNI Retractors and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nacleus material, spinal fusion, or insertion of spinal implants.

Source page: https://510kreport.com/device/K043602
Methodology: https://510kreport.com/methodology