510(k) Report

Devices descending from K160071

3 later devices reach StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+1K202338SpaceFlex ShoulderG21, S.R.L.20211—
+2K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—