Class Class II
OptiVu™ Shoulder (K250108)
Description
OptiVu™ Shoulder by Mr Surgical Solutions, LLC, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250108
Clearance Date2025-07-09
Clearance TypeTraditional
Product CodeSBF
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250108
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. OptiVu™ Shoulder (K250108) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243975 | Knee+ | Pixee Medical | 2025 |
| K233199 | ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) | 2024 |
| K210153 | NextAR RSA Platform | Medacta International S.A. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252170 | OptiVu Shoulder | Mr Surgical Solutions, LLC | 2025 |
Trace the full predicate network for K250108
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.