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…

Registry build 21.09.26

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.

5manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code OLO
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

Regulatory record for Dynamis Robotic Surgical System
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

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Dynamis Robotic Surgical System
Catalogue number Size Status
TPL0001-04 In distribution
TPL0001 In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer