PathKeeper Software
PathKeeper software provides planning, registration and navigation functions for posterior open spinal fusion surgery. Used with the PathKeeper camera and tracked tools, it helps surgeons…
PathKeeper software provides planning, registration and navigation functions for posterior open spinal fusion surgery. Used with the PathKeeper camera and tracked tools, it helps surgeons locate anatomy during thoracic, lumbar and sacral pedicle screw placement when preoperative CT images are available.
Installed on the workstation, the software links preoperative CT data with three-dimensional optical images of exposed bone. It guides the user through surface model creation, image acquisition, registration and verification. Tool positions and orientations are then displayed relative to the registered anatomy.
Navigation Setup
Dynamic reference frames on the tools and spine provide tracking references. The software performs the system’s computations and displays guidance; the camera, reference frames and surgical tools are separate physical components.
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 | Pathkeeper Surgical 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) | K222355 |
| Record published | 2023-04-23 |
| Record revised | 2025-04-04 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSW0001-01 | In distribution |
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 |
|---|---|
| K222355 | 2023-03-08 |
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.