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Orthopedic Augmented Reality
FDA product code SBF · Class 2 · Neurology
734
Registered devices
4
Adverse events
2
Recalls
43
510(k) clearances
Devices with this code
XVISION Instrument Tray — AUGMEDICS LTDNextAR Spine Platform — Medacta International SAPerc Pin Adaptor — AUGMEDICS LTDMyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International SANextAR Hip Platform — Medacta International SAMixed Reality Spine Navigation — Brainlab SEStandard xvision tray, instruments included — AUGMEDICS LTDNextAR Spine Platform — Medacta International SAOptiVu Shoulder Humeral Reference Rod — MR Surgical Solutions LLCNextAR Spine Platform — Medacta International SANextAR Hip Platform — Medacta International SANavi Tracker — Taiwan Main Orthopaedic Biotechnology Co., Ltd.MyKnee NextAR Tibial Distal Cutting Block Efficiency — Medacta International SANextAR Spine Platform — Medacta International SANextAR TKA Platform — Medacta International SANavigation Cart — Taiwan Main Orthopaedic Biotechnology Co., Ltd.MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International SANextAR Spine Platform — Medacta International SAKneePlus — PIXEE MEDICALNextAR Spine Platform — Medacta International SAMyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International SAMyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International SAMyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International SANextAR TKA Platform — Medacta International SA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | Kico Knee Innovation Company | Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing |
| 2025-09-19 | Kico Knee Innovation Company | Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion. |
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