Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
SBF — Predicate Candidate Screening
43 FDA 510(k) clearances under this product code; the 50 most recent screened below.
111 daysmedian FDA review time
261 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261854 | xvision Spine system | Augmedics, Ltd. | 2026-07-31 | 58 | 0 |
| K253805 | Knee+ | Pixee Medical S.A.S. | 2026-04-24 | 147 | 0 |
| K252847 | NextAR Hip Platform | Medacta International S.A. | 2026-01-09 | 123 | 0 |
| K251639 | xvision Spine system | Augmedics, Ltd. | 2025-10-03 | 127 | 0 |
| K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2025-09-29 | 90 | 0 |
| K252530 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025-09-10 | 30 | 0 |
| K251737 | NextAR(TM) Shoulder Platform | Medacta International S.A. | 2025-09-04 | 90 | 0 |
| K252170 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025-08-08 | 29 | 0 |
| K250477 | NextAR(TM) Spine | Medacta International S.A. | 2025-07-31 | 162 | 0 |
| K250108 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025-07-09 | 174 | 0 |
| K241525 | ExcelsiusXR™ | Globus Medical, Inc. | 2025-07-08 | 404 | 0 |
| K242569 | Mixed Reality Spine Navigation | Brainlab AG | 2025-05-16 | 261 | 0 |
| K243980 | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | 2025-03-21 | 88 | 1 |
| K243975 | Knee+ | Pixee Medical | 2025-03-20 | 87 | 0 |
| K250255 | xvision Spine system | Augmedics, Ltd. | 2025-03-13 | 44 | 0 |
| K243950 | ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. | 2025-01-13 | 21 | 2 |
| K243623 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2024-12-24 | 29 | 1 |
| K242271 | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2024-10-30 | 90 | 0 |
| K241481 | xvision Spine System | Augmedics, Ltd. | 2024-10-16 | 145 | 0 |
| K241870 | OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. | 2024-08-19 | 53 | 0 |
| K233172 | NextAR™ Spine Platform | Medacta International S.A. | 2024-04-24 | 209 | 0 |
| K233899 | Knee+ | Pixee Medical | 2024-03-08 | 88 | 0 |
| K232176 | STELLAR Knee | Polarisar, Inc. | 2023-11-02 | 104 | 0 |
| K232280 | NextAR™ TSA Platform | Medacta International S.A. | 2023-10-29 | 90 | 0 |
| K231284 | OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. | 2023-09-08 | 128 | 0 |
| K231611 | HOLO Portal™ Surgical Guidance System | Surgalign Spine Technologies | 2023-08-31 | 90 | 0 |
| K223769 | NextAR™ Spine Platform | Medacta International S.A. | 2023-07-21 | 218 | 0 |
| K230567 | OptiVu™ ROSA® MxR | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-06-13 | 104 | 0 |
| K230789 | Knee+ | Pixee Medical | 2023-04-21 | 30 | 0 |
| K220554 | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2022-12-16 | 291 | 0 |
| K220905 | xvision Spine System | Augmedics, Ltd. | 2022-11-17 | 234 | 0 |
| K213034 | SpineAR SNAP | Surgical Theater, Inc. | 2022-09-29 | 373 | 0 |
| K220104 | Knee+ | Pixee Medical | 2022-09-01 | 232 | 0 |
| K220733 | OptiVu ROSA MxR | Orthosoft Inc (D/B/A Zimmer Cas) | 2022-07-29 | 137 | 0 |
| K213751 | NextAR™ TKA Platform My Knee PPS | Medacta International S.A. | 2022-03-10 | 100 | 0 |
| K211254 | ARAI Surgical Navigation System | Surgalign Spine Technologies | 2022-01-14 | 263 | 0 |
| K210859 | NextAR™ Spine Platform | Medacta International S.A. | 2021-11-05 | 227 | 0 |
| K211188 | xvision Spine system (XVS) | Augmedics, Ltd. | 2021-07-19 | 90 | 1 |
| K210153 | NextAR RSA Platform | Medacta International S.A. | 2021-05-12 | 111 | 1 |
| K202750 | Knee+ | Pixee Medical | 2021-04-21 | 212 | 0 |
| K202152 | NextAR TKA Platform | Medacta International S.A. | 2020-10-27 | 85 | 0 |
| K193559 | NextAR TKA Platform | Medacta Inernational SA | 2020-07-10 | 200 | 0 |
| K190929 | xvision Spine system (XVS) | Augmedics, Ltd. | 2019-12-20 | 255 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda