Dynamis Robotic Surgical System
Basic Information
- Brand Name
- Dynamis Robotic Surgical System
- Primary DI
- 07649998256025
- Version / Model
- TPL0001
- Company Name
- LEM Surgical AG
- Labeler DUNS
- 480538984
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-14
- Public Version
- 2
- Public Version Date
- 2026-03-19
- Public Version Status
- Update
- Public Device Record Key
- 7c77c339-30be-4518-a340-e87d9527dfbd
Device Description
The Dynamis System is an integrated navigation-based robotic platform with real-time tracking capability for spine surgical procedures that include thoracic, lumbar, and sacral approaches. Dynamis is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding qualified surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans. The system is indicated for the placement of non-cervical spinal pedicle screws and is intended for use with any legally marketed spinal system that contains instruments meeting the criteria for use with the Dynacan end effectors of the Dynamis System.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38723 | Robotic surgical navigation system | An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It typically consists of an operator's console featuring a robotic surgical arm(s) and a video camera used to track the robotic instrumentation. The input to the computer is usually by means of an existing CT or MRI scan. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07649998256025 | GS1 |
Customer Contacts
- Phone
- +1 (844) 684-9483
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243326 | 000 |