Class Class II
Mpact 3D Metal Augments II (K242232)
Description
Mpact 3D Metal Augments II by Medacta International S.A., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242232
Clearance Date2025-04-23
Clearance TypeTraditional
Product CodeLPH
Regulation Number888.3358
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242232
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. Mpact 3D Metal Augments II (K242232) cites 5 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 |
| K171966 | Mpact® 3D Metal Implants and Augments 3D Metal | Medacta International S.A. | 2018 |
| K170690 | M-Vizion Femoral Revision System | Medacta International S.A. | 2017 |
| K170149 | 3DMetal Tibial Cones | Medacta International S.A. | 2017 |
| K170910 | Medacta Anatomic Shoulder Prosthesis | Medacta International S.A. | 2017 |
Trace the full predicate network for K242232
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.