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Orthopedic Augmented Reality
FDA product code SBF · Class 2 · Neurology
720
Registered devices
4
Adverse events
2
Recalls
43
510(k) clearances
Devices with this code
OnPoint Fixed Adapter with Tap Array — OnPoint Surgical, Inc.MyKnee NextAR Tibial Distal Cutting Block Efficiency — Medacta International SAPerc Mallet 250 gr. — AUGMEDICS LTDMyKnee NextAR Tibial Distal Cutting Block Efficiency — Medacta International SANextAR TKA Platform — Medacta International SANextAR Spine Platform — Medacta International SANextAR (TM) Shoulder Platform — Medacta International SANextAR TKA 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™ Spine — Medacta International SANextAR Spine Platform — Medacta International SAMyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International SAReplacement Velcro for Headset — OnPoint Surgical, Inc.NextAR Spine Platform — Medacta International SAMyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International SABone Drill — Taiwan Main Orthopaedic Biotechnology Co., Ltd.ARVIS ® — KICO KNEE INNOVATION COMPANY PTY LIMITEDPerc Pin 150mm 5 units Package — AUGMEDICS LTDMyKnee NextAR Tibial Distal Cutting Block Efficiency — Medacta International SANextAR TKA Platform — Medacta International SANextAR Knee Platform — Medacta International SAConnection System — Taiwan Main Orthopaedic Biotechnology Co., Ltd.
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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