DEPLOYDatabase

Incident · Regulatory action

LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system

FDA's K260369 record documents a June 20, 2026 510(k) decision for LEM Surgical's Dynamis Robotic Surgical System, including expanded navigation capabilities and vertebra tracking (FDA K260369).

Occurred 2026-06-23 · Dynamis Robotic Surgical System at Switzerland, Europe · LEM Surgical · Switzerland, Europe · Surgical robots · Investigated by FDA

How to read this record

Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system

Machine-readable surfaces

Sources (2)

  1. https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260369.pdf · 2026-06-20
  2. https://thespinemarketgroup.com/lem-surgical-announces-second-fda-510k-clearance-for-next-generation-humanoid-robotic-surgical-system/

Status history

  • Active · 2026-07-03 · agent:depth

Common questions

What happened in LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system?
FDA's K260369 record documents a June 20, 2026 510(k) decision for LEM Surgical's Dynamis Robotic Surgical System, including expanded navigation capabilities and vertebra tracking ([FDA K260369](https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260369.pdf)).
When did this incident occur?
The incident is recorded as occurring on June 23, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system?
Dynamis Robotic Surgical System by LEM Surgical is the recorded robot involved in this incident at Switzerland, Europe.
Has anyone responded to LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 2 sources (1 primary) · last reviewed 2026-09-29

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-09-29

Sources by quality tier

1
primary-fda-database
FDA database
1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system.

Deploy Watch

Track this incident.

We notify you when the regulator updates the record, the remedy status changes, or a related incident surfaces.

Canonical ID dfd7a602-92b3-4537-8cae-7735bb6e3785