Dynamis Robotic Surgical System
Dynamis assists surgeons with locating anatomical structures and positioning an instrument holder or guide tube to navigate or guide qualified instruments. The indicated procedures may be…
Dynamis assists surgeons with locating anatomical structures and positioning an instrument holder or guide tube to navigate or guide qualified instruments.
The indicated procedures may be open or percutaneous, when required fiducial markers and rigid anatomy can be identified on intraoperative CT scans.
Listed Item
The Dynamis Robotic Surgical System is an integrated navigation-based robotic platform with real-time tracking capability for spine surgical procedures that include cervical, thoracic, lumbar, and sacral approaches. The system is comprised of two computer-controlled robotic arms to support surgical robotic guidance, while a third robotic arm holds and controls the Scout navigation camera. All components are integrated into one physical cart located partially underneath the surgical table. The cart employs bilateral elevator mechanisms to deploy and fold the surgical robotic arms and secure them. This system functions in conjunction with different intraoperative imaging systems by data transfer of DICOM format images by USB and/or Direct LAN transfer for intraoperative planning. The system software is responsible for all motion control, navigation, data storage, user management, case management, and safety functions. The system establishes registration between the virtual patient (points on the patient DICOM images) and the physical patient (corresponding to the patient’s anatomy). The information of the plan, coupled with the registration, provides the necessary information to give visual assistance to the surgeon during the robotic alignment of qualified instruments or during free-hand navigation. Qualified instruments that are rigid, straight, round, and concentric are permitted for use through the Dynacan or used with the Dynatracker, given they pass the Instrument Setup process. The system also supports individual vertebra tracking to maintain alignment to vertebra specific trajectories by monitoring relative vertebral motion, as well as a stabilization workflow which provides additional control of vertebral motion during instrumentation.
Navigation Workflow
System software handles motion control, navigation, data storage, user management, case management and safety functions. It registers points on the patient DICOM images with the physical anatomy to support visual assistance during robotic alignment or freehand navigation.
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 | LEM Surgical Inc, United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K260369 |
| Record published | 2026-07-07 |
| Record revised | 2026-03-19 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TPL0001-04 | In distribution | |
| TPL0001 | 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 |
|---|---|
| K260369 | 2026-06-20 |
| K243326 | 2025-04-23 |
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.