KWZ

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Product code
KWZ
Device name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device class
Class 2
21 CFR
21 CFR 888.3310
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
34 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-07-31.

NumberDecision dateApplicantDevice nameSummary
K2414612025-07-31Medacta International S.A.Mpact Constrained LinerPDF
K2406392024-04-04Depuy Ireland UCPINNACLETM Constrained Acetabular LinersPDF

2 summaries are archived here for direct download.

Official FDA classification page: KWZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).