# K163221: Mazor X

- Pathway: 510(k) (Traditional)
- Applicant: Mazor Robotics, Ltd.
- Decided: Apr 4, 2017 after 139 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: 13 generations back to K911783 (1994). 59 ancestors in all.
19 later devices descend from it; 2 cite it directly.
1 of 79 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152041: Renaissance X System, Mazor Robotics, Ltd. (2015) Summary page 4.
- K111019: Surgimap (TM) Spine, Nemaris, Inc. (2011) Summary page 4.

## Most influential descendants
- 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
- K211441: Navigated Anterolateral Disc Prep Instruments (2021), 9 descendants of its own

## Indications for use
The Mazor X 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. Mazor 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/K163221
Methodology: https://510kreport.com/methodology