510(k) Report

Devices descending from K023102

306 later devices reach Accolade TMZF Plus HA 127 Size 0 Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+9K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+9K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+9K221104Actera™ hip systemConformis, Inc.202211
+10K252067Velora Acetabular SystemRestor3D, Inc.20250—
+10K231178ACTERA™ hip systemConformis, Inc.20230—