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510(k) K230789

Knee+ by Pixee Medical — Product Code SBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2023
Date Received
March 22, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Augmented Reality
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as “augmented reality” stereoscopic images to intraoperatively augment the user’s field of view.

Other clearances by Pixee Medical

  • K243975 — Knee+ (March 20, 2025)
  • K233899 — Knee+ (March 8, 2024)
  • K220104 — Knee+ (September 1, 2022)
  • K213922 — FX SPS (July 22, 2022)
  • K202750 — Knee+ (April 21, 2021)

Other clearances for product code SBF

  • K252847 — NextAR Hip Platform (January 9, 2026)
  • K251639 — xvision Spine system (October 3, 2025)
  • K252054 — SpineAR SNAP (SyncAR Spine) (September 29, 2025)
  • K252530 — OptiVu™ Shoulder (September 10, 2025)
  • K251737 — NextAR(TM) Shoulder Platform (September 4, 2025)
  • K252170 — OptiVu™ Shoulder (August 8, 2025)
  • K250477 — NextAR(TM) Spine (July 31, 2025)
  • K250108 — OptiVu™ Shoulder (July 9, 2025)
  • K241525 — ExcelsiusXR™ (July 8, 2025)
  • K242569 — Mixed Reality Spine Navigation (May 16, 2025)