_Regulation · Permit_

# FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty

Canonical ID: `7157516d-5757-4677-b171-68eb5a6c916f`

- **Jurisdiction:** [United States](/locations/united-states.md) (id: `aa8b9c05-c836-4021-801f-59801970401e`)
- **Kind:** `permit`
- **Status (derived):** in_effect
- **Effective:** 2026-05-01

FDA granted 510(k) clearance for Pixee Medical Knee+ NexSight, an augmented reality navigation platform for total knee arthroplasty (TKA).

## Sources (1)

1. https://www.todaysmedicaldevelopments.com/news/regulatory-roundup-may-2026/ · 2026-05-01

## Status history

- **in_effect** · 2026-05-01 · agent-recon
    - Initial ingestion

## Common questions

### What does FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty cover?

FDA granted 510(k) clearance for Pixee Medical Knee+ NexSight, an augmented reality navigation platform for total knee arthroplasty (TKA).

### Where does FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty apply?

FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty is recorded as a permitting requirement applying in United States on the DEPLOY registry.

### When did FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty take effect?

FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty is recorded as effective May 1, 2026 on the DEPLOY registry.

### Is FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty still in effect?

FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty is currently in effect and applies to covered operators in the named jurisdiction.

### What types of robots does FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty apply to?

FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty is recorded as applying to surgical on the DEPLOY registry.

### Which robot models on the DEPLOY registry fall under FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty?

8 robot models on the DEPLOY registry match the form-factor scope of FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty: ANOVO, Andromeda Surgical Robot, CORI, Carina and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.


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