510(k) Report

Devices descending from K993339

5 later devices reach Endopearl with Threader through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012469Resorbable NO Profile Screw and WasherBiomet Manufacturing, Inc.20014—
+2K021832Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherBiomet, Inc.20023—
+3K051069Nonresorbable Centraloc Tibial Screw & WasherArthrotek, Inc.20050—
+3K033233Lactosorb Tibial L-15 Screw and WasherBiomet, Inc.20032—
+4K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130—