510(k) Report

Devices descending from K060535

8 later devices reach Spacer-S Temporary Shoulder Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+1K112983Spacer-STecres S.P.A.20117—
+2K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+2K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+2K202338SpaceFlex ShoulderG21, S.R.L.20211—
+2K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+2K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+3K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—