Class Class II
MectaLIF 3D Metal (K251016)
Description
MectaLIF 3D Metal by Medacta International S.A., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251016
Clearance Date2025-07-17
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251016
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. MectaLIF 3D Metal (K251016) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221850 | GMK 3D Metal Tibial Tray | Medacta International S.A. | 2022 |
| K202568 | Mpact® 3D Metal Implants - DMLS Technology | Medacta International S.A. | 2021 |
| K212831 | MectaLIF Extension | Medacta International S.A. | 2021 |
| K181970 | MectaLIF Posterior Extension | Medacta International S.A. | 2018 |
| K133192 | MECTALIF TIPEEK | Medacta International | 2014 |
| K131671 | MECTALIF | Medacta International | 2013 |
| K110927 | MECTALIF | Medacta International | 2011 |
Trace the full predicate network for K251016
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.