# K191012: Navigated Pedicle Access Kit

- Pathway: 510(k) (Traditional)
- Applicant: Izi Medical Products, LLC
- Decided: Aug 7, 2019 after 113 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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 K050438 (2005). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180352: 7D Surgical System, 7D Surgical, Inc. (2018) Summary page 4.

## Most influential descendants
- K232800: Navigation Tracking Instruments (2024), 0 descendants of its own

## Indications for use
The Navigated Pedicle Access Kit is intended to be used in image guided surgery with the 7D Surgical System. The Navigated Pedicle Access Kit is intended for use in posterior spinal surgery to assist in the accurate placement of pedicle screws. The device is sterile and designed for single use.

Source page: https://510kreport.com/device/K191012
Methodology: https://510kreport.com/methodology