# K172522: Mazor X

- Pathway: 510(k) (Special)
- Applicant: Mazor Robotics, Ltd.
- Decided: Sep 15, 2017 after 25 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: 14 generations back to K911783 (1994). 76 ancestors in all.
No later device cites it as a predicate yet.
1 of 77 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163221: Mazor X, Mazor Robotics, Ltd. (2017) Summary page 4.
- K101791: Rosa Surgical Device, Medtech S.A.S (2010) Summary page 4.
- K151511: ROSA Spine, Medtech S.A (2016) Summary page 4.

## 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/K172522
Methodology: https://510kreport.com/methodology