Class Class II
Mpact Constrained Liner (K241461)
Description
Mpact Constrained Liner by Medacta International S.A., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241461
Clearance Date2025-07-31
Clearance TypeTraditional
Product CodeKWZ
Regulation Number888.3310
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241461
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 Constrained Liner (K241461) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200391 | MPACT Extension | Medacta International S.A. | 2021 |
| K131458 | MPACT DM LINER CONVERTER | Medacta International | 2013 |
| K111635 | SMITH & NEPHEW RJ CONSTRAINED LINERS | Smith & Nephew, Inc. | 2011 |
| K103721 | MPACT ACETABULAR SYSTEM | Medacta International | 2011 |
| K092265 | VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS | Medacta International S.A. | 2010 |
| K091967 | MEDACTA BIPOLAR HEAD | Medacta International S.A. | 2010 |
| K061654 | TRIDENT CONSTRAINED ACETABULAR INSERT | Howmedica Osteonics Corp. | 2006 |
Trace the full predicate network for K241461
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.