Mazor X System
Mazor X System combines robotic trajectory guidance with navigation of surgical instruments to position instruments or spinal implants according to a planned path. It is intended for open,…
Mazor X System combines robotic trajectory guidance with navigation of surgical instruments to position instruments or spinal implants according to a planned path. It is intended for open, minimally invasive or percutaneous spinal procedures.
The navigation function tracks instrument position relative to anatomy and shows it on diagnostic or intraoperative images. Imaging functions can display implants on patient CT data.
Three-Dimensional Imaging
The system processes two-dimensional projections from standard C-arms into volumetric three-dimensional images of high-contrast objects. The described configuration also supports interbody implant planning on the main planning screen and navigation of compatible instruments used for interbody placement.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Mazor Robotics Ltd., Israel |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K203005 |
| Record published | 2020-12-31 |
| Record revised | 2025-07-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-07-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TPL0059-08 | In distribution | |
| TPL0059-07 | In distribution | |
| TPL0059-10 | In distribution | |
| TPL0059-09 | In distribution | |
| TPL0059-05 | Withdrawn | |
| TPL0059-04 | Withdrawn | |
| TPL0059-06 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251316 | 2025-09-11 |
| K230064 | 2023-04-07 |
| K203005 | 2020-10-27 |
| K200935 | 2020-05-08 |
| K182077 | 2018-11-02 |
| K180307 | 2018-04-30 |
| K172522 | 2017-09-15 |
| K163221 | 2017-04-04 |
| K152041 | 2015-11-17 |
| K140167 | 2014-09-10 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mazor Robotics Ltd. | 510(k) number | 2025-12-10 | Class II | Under Investigation by firm | Software errors that can result in incorrect surgical instrument positioning during spinal surgery. | 549 systems |
| Mazor Robotics Ltd. | 510(k) number | 2024-07-17 | Class II | Device Design | Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen. | 94 devices |
| Mazor Robotics Ltd. | 510(k) number | 2023-09-05 | Class II | Software design | Software update | 324 devices |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-07-02 | Class II | Other | The firm has become aware that the Snapshot Trackers were not manufactured in accordance with specifications and could potentially lead to navigational inaccuracies, which may result in patient injury, e.g. nerve damage or neurological def | 93 snapshot trackers | 2022-02-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.