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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthopedic augmented reality
Regulation Description Stereotaxic instrument.
Definition 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.
Product CodeSBF
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
AUGMEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 5
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KICO KNEE INNOVATION COMPANY PTY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KICO KNEE INNOVATION COMPANY PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 9
MR SURGICAL SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ONPOINT SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOSOFT INC (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 2
PIXEE MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
PIXEE MEDICAL S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
POLARISAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGALIGN SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL THEATER, INC.
  SUBSTANTIALLY EQUIVALENT 3
TAIWAN MAIN ORTHOPAEDIC BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2025 1 1
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Movement Disorder 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Kico Knee Innovation Company II Oct-14-2025
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