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)
Top companies in SBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Medacta International S.A. | 10 | 0 |
| Augmedics, Ltd. | 7 | 0 |
| Pixee Medical | 5 | 0 |
| Kico Knee Innovation Company Pty Limited | 2 | 2 |
| Mr Surgical Solutions, LLC | 3 | 0 |
| Surgical Theater, Inc. | 3 | 0 |
| Onpoint Surgical, Inc. | 2 | 0 |
| Orthosoft Inc (D/B/A Zimmer Cas) | 2 | 0 |
| Surgalign Spine Technologies | 2 | 0 |
| Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Kico Knee Innovation Company Brand Name: Kico Knee Innovation
Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2
Model/Catalog Number: IN-29200
Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200)
ARVIS S Open, Classified |
SBF | K243950 K243980 |
| Oct 14, 2025 | Kico Knee Innovation Company Brand Name: ARVIS
Product Name: ARVIS" Shoulder
Model/Catalog Number: IN-27300, Arvis Surgical Planning Software
Software Version: V2025.1.2
Product Description: Intended Use: The ARVIS" system is a c Open, Classified |
SBF | K243950 |
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