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510(k) K251737

NextAR(TM) Shoulder Platform by Medacta International S.A. — Product Code SBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2025
Date Received
June 6, 2025
Clearance Type
Traditional
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 Medacta International S.A.

  • K253328 — GMK 3D Metal Tibial Tray Extension (February 26, 2026)
  • K250644 — MSS - Monobloc stem (February 3, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252847 — NextAR Hip Platform (January 9, 2026)
  • K242603 — MyPAO SA guides (November 19, 2025)
  • K250338 — MSS - Humeral reverse liners extension (October 31, 2025)
  • K250450 — Coated hip implants (September 19, 2025)
  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K241461 — Mpact Constrained Liner (July 31, 2025)
  • K250477 — NextAR(TM) Spine (July 31, 2025)

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