510(k) Report

Devices descending from K161273

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213287StageOne Knee Cement Spacer MoldsBiomet, Inc.20220—
+1K201960SpaceFlex Knee - 80mm SizeG21, S.R.L.20200—
+1K190216SpaceFlex KneeG21, S.R.L.20191—