# K140167: Renaissance X System

- Pathway: 510(k) (Traditional)
- Applicant: Mazor Robotics, Ltd.
- Decided: Sep 10, 2014 after 230 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: 11 generations back to K911783 (1994). 35 ancestors in all.
21 later devices descend from it; 1 cites it directly.
1 of 57 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113228: Renaissance System, Mazor Robotics, Ltd. (2011) Summary page 4.

## Most influential descendants
- K152041: Renaissance X System (2015), 20 descendants of its own
- K163221: Mazor X (2017), 19 descendants of its own
- K180307: Mazor X (2018), 17 descendants of its own
- K182077: Mazor X System (Mazor X Stealth Edition) (2018), 16 descendants of its own
- K200935: Mazor X (2020), 15 descendants of its own

## Indications for use
The Renaissance X System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or minimally invasive or percutaneous procedures. Renaissance X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.

Source page: https://510kreport.com/device/K140167
Methodology: https://510kreport.com/methodology