Mpact Constrained Liner
K-Number: K241461 · 2025-07-31
ApplicantMedacta International S.A.
Decision Date2025-07-31
Product CodeKWZ
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Mpact Constrained Liner is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2025-07-31 under approval number K241461. The device is classified under product code KWZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Mpact Constrained Liner?
Mpact Constrained Liner is a medical device that received FDA 510(k) clearance on 2025-07-31. It is manufactured by Medacta International S.A.. The 510(k) number is K241461.
When was Mpact Constrained Liner approved by the FDA?
Mpact Constrained Liner received FDA 510(k) clearance on 2025-07-31, under approval number K241461.
What company makes Mpact Constrained Liner?
Mpact Constrained Liner is manufactured by Medacta International S.A..
What is the FDA product code for Mpact Constrained Liner?
The FDA product code for Mpact Constrained Liner is KWZ.
Other Devices by Medacta International S.A.
Related Devices (Code: KWZ)
K161610EXPRT Revision Hip SystemEncore Medical L.P.
K162641Smith & Nephew, Inc. R3 Constrained LinerSmith & Nephew, Inc.
K163497EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture BoltEncore Medical L.P.
K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.