Class Class II
MOTO Partial Knee System Extension (K251618)
Description
MOTO Partial Knee System Extension by Medacta International S.A., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251618
Clearance Date2025-07-24
Clearance TypeTraditional
Product CodeHSX
Regulation Number888.3520
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251618
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. MOTO Partial Knee System Extension (K251618) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | 2021 |
| K183029 | MOTO Partial Knee System | Medacta International S.A. | 2019 |
| K162084 | MOTO Partial Knee System | Medacta International S.A. | 2017 |
| K133940 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEAR... | Biomet UK, Ltd. | 2014 |
Trace the full predicate network for K251618
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.