Class Class II
ROSA® Knee System (K242864)
Description
ROSA® Knee System by Orthosoft Inc. (d/b/a) Zimmer CAS, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242864
Clearance Date2024-10-18
Clearance TypeSpecial
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242864
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. ROSA® Knee System (K242864) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230243 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | 2023 |
Trace the full predicate network for K242864
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.