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Regulation · Permit

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

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

Jurisdiction: United States · Effective 2026-05-01

Machine-readable surfaces

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.
Methodology: Unreviewed · 1 source (no primary) · last reviewed 2026-08-09

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Architectural position

Cohort: surgical

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: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty.

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