510(k) Report

Devices descending from K171966

3 later devices reach Mpact® 3D Metal™ Implants and Augments 3D Metal™ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+1K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+2K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—