_Incident · Regulatory action_

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

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

- **Occurred:** 2022-08-23
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Deployment:** [POINT Kinguide Robotic-Assisted Surgical System at United States (multiple hotel chains)](/deployments/point-kinguide-united-states-usa.md) (id: `2868040e-e8e5-440d-9e48-8cb437762e96`)
- **Model:** [POINT Kinguide Robotic-Assisted Surgical System](/models/point-kinguide.md) (id: `99759655-9bb0-4df2-92b8-1abe269e2a73`)
- **Company:** [Point Robotics MedTech](/companies/point-robotics-medtech.md) (id: `0dec23ef-613c-43e8-a3ec-1e58c783bc43`)
- **Location:** [United States (multiple hotel chains)](/locations/united-states-usa.md) (id: `828f9784-5535-4787-a6ea-4e2d27c3926f`)
- **Category:** [Surgical robots](/surgical)

[Point Robotics MedTech](/companies/point-robotics-medtech.md) received FDA 510(k) clearance for its [POINT Kinguide Robotic-Assisted Surgical System](/models/point-kinguide.md), the first hand-held spinal surgical robot from Taiwan. The system is cleared for minimally invasive spine surgery procedures.

## 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.


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