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510(k) K252170

OptiVu™ Shoulder by Mr Surgical Solutions, LLC — Product Code SBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2025
Date Received
July 10, 2025
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 Mr Surgical Solutions, LLC

  • K252530 — OptiVu™ Shoulder (September 10, 2025)
  • K250108 — OptiVu™ Shoulder (July 9, 2025)
  • K981809 — CAROLINE GUIDE (August 14, 1998)
  • K973277 — CAROLINE GUIDE/DELIA LOCALIZER (November 17, 1997)

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)
  • 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)
  • K243980 — ARVIS Surgical Navigation System (March 21, 2025)