# K260369: Dynamis Robotic Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: LEM Surgical AG
- Decided: Jun 20, 2026 after 135 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K040583 (2004). 428 ancestors in all.
No later device cites it as a predicate yet.
1 of 429 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243326: Dynamis Robotic Surgical System, LEM Surgical AG (2025) Summary page 5.

## Indications for use
The Dynamis Robotic Surgical System 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 intraoperative CT scans. The Dynamis Robotic Surgical System is indicated for the placement of spinal pedicle screws.

Source page: https://510kreport.com/device/K260369
Methodology: https://510kreport.com/methodology