510(k) Report

Devices descending from K121011

10 later devices reach Amistem and Quadra - Line Extension through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250450Coated hip implantsMedacta International S.A.20250—
+1K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+2K251166Mfinity Femoral SystemMedacta International S.A.20250—
+2K192126AMIStem-P Short NeckMedacta International S.A.20191—
+2K181254Quadra PMedacta International S.A.20187—
+3K202730Quadra-PMedacta International S.A.20201—
+3K192827Quadra-PMedacta International S.A.20206—
+4K220405Amis K LongMedacta International S.A.20220—
+4K210062Mectaplug PE IIMedacta International S.A.20210—
+4K203041SMS Cementless StemMedacta International S.A.20201—