# K203005: Mazor X

- Pathway: 510(k) (Special)
- Applicant: Mazor Robotics, Ltd.
- Decided: Oct 27, 2020 after 26 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K911783 (1994). 69 ancestors in all.
14 later devices descend from it; 2 cite it directly.
4 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200935: Mazor X, Mazor Robotics, Ltd. (2020) Summary page 4.

## Most influential descendants
- K211441: Navigated Anterolateral Disc Prep Instruments (2021), 9 descendants of its own
- K240625: CORUS Navigation Access System (2024), 4 descendants of its own
- K230064: Mazor X System (Mazor X Stealth Edition) (2023), 3 descendants of its own
- K232345: ATEC Posterior Navigated Disc Prep Instruments (2023), 2 descendants of its own
- K260329: Ion-C Navigation Instruments (2026), 1 descendant of its own

## Recalls of this device
- Sep 5, 2023 · Class II · Z-0101-2024: Software update

## Indications for use
The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. It may be used in 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. The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.

Source page: https://510kreport.com/device/K203005
Methodology: https://510kreport.com/methodology