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Orthopedic Augmented Reality

Regulation 882.4560

3510(k)s in 12 months (43 all time)
1recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in SBF

Company510(k)sRecalls
Medacta International S.A.100
Augmedics, Ltd.70
Pixee Medical50
Kico Knee Innovation Company Pty Limited22
Mr Surgical Solutions, LLC30
Surgical Theater, Inc.30
Onpoint Surgical, Inc.20
Orthosoft Inc (D/B/A Zimmer Cas)20
Surgalign Spine Technologies20
Taiwan Main Orthopaedic Biotechnology Co., Ltd.20
Decided510(k)Device and applicantCode
Jul 31, 2026K261854xvision Spine system
Augmedics, Ltd., IL
SBF
Apr 24, 2026K253805Knee+
Pixee Medical S.A.S., FR
SBF
Jan 9, 2026K252847NextAR Hip Platform
Medacta International S.A., CH
SBF
Oct 3, 2025K251639xvision Spine system
Augmedics, Ltd., IL
SBF
Sep 29, 2025K252054SpineAR SNAP (SyncAR Spine)
Surgical Theater, Inc.
SBF
Sep 10, 2025K252530OptiVu™ Shoulder
Mr Surgical Solutions, LLC
SBF
Sep 4, 2025K251737NextAR(TM) Shoulder Platform
Medacta International S.A., CH
SBF
Aug 8, 2025K252170OptiVu™ Shoulder
Mr Surgical Solutions, LLC
SBF
Jul 31, 2025K250477NextAR(TM) Spine
Medacta International S.A., CH
SBF
Jul 9, 2025K250108OptiVu™ Shoulder
Mr Surgical Solutions, LLC
SBF
Jul 8, 2025K241525ExcelsiusXR™
Globus Medical, Inc.
SBF
May 16, 2025K242569Mixed Reality Spine Navigation
Brainlab AG, DE
SBF
Mar 21, 2025K243980ARVIS Surgical Navigation System
Kico Knee Innovation Company Pty Limited, AU
SBF
Mar 20, 2025K243975Knee+
Pixee Medical, FR
SBF
Mar 13, 2025K250255xvision Spine system
Augmedics, Ltd., IL
SBF
Jan 13, 2025K243950ARVIS® Shoulder
Kico Knee Innovation Company Pty, Ltd., AU
SBF
Dec 24, 2024K243623SpineAR SNAP (SyncAR Spine)
Surgical Theater, Inc.
SBF
Oct 30, 2024K242271Caduceus S
Taiwan Main Orthopaedic Biotechnology Co., Ltd., TW
SBF
Oct 16, 2024K241481xvision Spine System
Augmedics, Ltd., IL
SBF
Aug 19, 2024K241870OnPoint Augmented Reality Spine System
Onpoint Surgical, Inc.
SBF
Apr 24, 2024K233172NextAR™ Spine Platform
Medacta International S.A., CH
SBF
Mar 8, 2024K233899Knee+
Pixee Medical, FR
SBF
Nov 2, 2023K232176STELLAR Knee
Polarisar, Inc.
SBF
Oct 29, 2023K232280NextAR™ TSA Platform
Medacta International S.A., CH
SBF
Sep 8, 2023K231284OnPoint Augmented Reality Spine System
Onpoint Surgical, Inc.
SBF
Aug 31, 2023K231611HOLO Portal™ Surgical Guidance System
Surgalign Spine Technologies
SBF
Jul 21, 2023K223769NextAR™ Spine Platform
Medacta International S.A., CH
SBF
Jun 13, 2023K230567OptiVu™ ROSA® MxR
Orthosoft Inc (D/B/A Zimmer Cas), CA
SBF
Apr 21, 2023K230789Knee+
Pixee Medical, FR
SBF
Dec 16, 2022K220554Caduceus S
Taiwan Main Orthopaedic Biotechnology Co., Ltd., TW
SBF
Nov 17, 2022K220905xvision Spine System
Augmedics, Ltd., IL
SBF
Sep 29, 2022K213034SpineAR SNAP
Surgical Theater, Inc.
SBF
Sep 1, 2022K220104Knee+
Pixee Medical, FR
SBF
Jul 29, 2022K220733OptiVu ROSA MxR
Orthosoft Inc (D/B/A Zimmer Cas), CA
SBF
Mar 10, 2022K213751NextAR™ TKA Platform My Knee PPS
Medacta International S.A., CH
SBF
Jan 14, 2022K211254ARAI Surgical Navigation System
Surgalign Spine Technologies
SBF
Nov 5, 2021K210859NextAR™ Spine Platform
Medacta International S.A., CH
SBF
Jul 19, 2021K211188xvision Spine system (XVS)
Augmedics, Ltd., IL
SBF
May 12, 2021K210153NextAR RSA Platform
Medacta International S.A., CH
SBF
Apr 21, 2021K202750Knee+
Pixee Medical, FR
SBF
Oct 27, 2020K202152NextAR TKA Platform
Medacta International S.A., CH
SBF
Jul 10, 2020K193559NextAR TKA Platform
Medacta Inernational SA, CH
SBF
Dec 20, 2019K190929xvision Spine system (XVS)
Augmedics, Ltd., IL
SBF

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