510(k) Report

Devices descending from K230011

3 later devices reach Mpact Extension through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+1K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+1K250450Coated hip implantsMedacta International S.A.20250—