FDA 510(k) Clearance: Pixee Medical Knee+ NexSight AR Surgical Navigation for Total Knee Arthroplasty
[in effect]United States · permit · permit
Jurisdiction
United States
Classification
permit
Status
in effect
Effective Date
May 1, 2026
Primary Sources
1 audited
Statutory Scope & Summary
FDA granted 510(k) clearance for Pixee Medical Knee+ NexSight, an augmented reality navigation platform for total knee arthroplasty (TKA).
Covered Sectors & Application Domains
Regulatory Analysis & Inquiries
6 entriesWhat 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.
Primary Sources & Legal Instruments
1 document- https://www.todaysmedicaldevelopments.com/news/regulatory-roundup-may-2026/Official Source
https://www.todaysmedicaldevelopments.com/news/regulatory-roundup-may-2026/