# K152041: Renaissance X System

- Pathway: 510(k) (Special)
- Applicant: Mazor Robotics, Ltd.
- Decided: Nov 17, 2015 after 118 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: 12 generations back to K911783 (1994). 37 ancestors in all.
20 later devices descend from it; 1 cites it directly.
1 of 58 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140167: Renaissance X System, Mazor Robotics, Ltd. (2014) Summary page 4.
- K120812: Renaissance, Mazor Robotics, Ltd. (2012) Summary page 4.

## Most influential descendants
- 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
- K203005: Mazor X (2020), 14 descendants of its own

## Indications for use
The modified Renaissance X System is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain 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/K152041
Methodology: https://510kreport.com/methodology