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Incident · Regulatory action

FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system

Point Robotics MedTech received FDA 510(k) clearance for its POINT Kinguide Robotic-Assisted Surgical System, the first hand-held spinal surgical robot from Taiwan. The system is cleared for minimally invasive spine surgery procedures.

Occurred 2022-08-23 · POINT Kinguide Robotic-Assisted Surgical System at United States (multiple hotel chains) · Point Robotics MedTech · United States (multiple hotel chains) · Surgical robots · Investigated by FDA

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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 FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system

Machine-readable surfaces

Sources (1)

  1. https://www.prnewswire.com/news-releases/first-ever-spinal-surgical-hand-held-robot-by-point-robotics-medtech-to-make-its-worldwide-debut-in-the-united-states-301635498.html · 2022-08-23

Status history

  • resolved · 2022-08-23

    FDA 510(k) clearance granted

Common questions

What happened in FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system?
Point Robotics MedTech received FDA 510(k) clearance for its POINT Kinguide Robotic-Assisted Surgical System, the first hand-held spinal surgical robot from Taiwan. The system is cleared for minimally invasive spine surgery procedures.
When did this incident occur?
The incident is recorded as occurring on August 23, 2022 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system?
POINT Kinguide Robotic-Assisted Surgical System by Point Robotics MedTech is the recorded robot involved in this incident at United States (multiple hotel chains).
Has anyone responded to FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery 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 FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Unreviewed · 1 source (no primary) · last reviewed 2026-08-21

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-21

Sources by quality tier

1
unclassified
Unclassified source

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

Methodology surface for FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system.

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Canonical ID c9707a20-3f6a-48ea-b789-0843a05d08f8