510(k) Report

Devices descending from K081679

8 later devices reach Revelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models 425-00… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130099Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019Encore Medical L.P.20134—
+1K122636Revelation Porous Coated Hip Stem, Size 8Encore Medical L.P.20120—
+1K120241Linear Hip Stem, Size 5Encore Medical L.P.201261
+2K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+2K223779EMPOWR™ blade stemEncore Medical, LLC20230—
+2K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P.201701