510(k) Report

Devices descending from K161166

2 later devices reach StageOne Select Cement Spacer Molds for Temporary Hip Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc.20220—
+1K192041G21 SpaceFlex HipG21, S.R.L.20190—