510(k) Report

Devices descending from K131135

4 later devices reach Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+2K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+2K202338SpaceFlex ShoulderG21, S.R.L.20211—
+3K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—