510(k) Report

Devices descending from K984171

6 later devices reach Endopearl through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993339Endopearl with ThreaderLinvatec Corp.19995—
+2K012469Resorbable NO Profile Screw and WasherBiomet Manufacturing, Inc.20014—
+3K021832Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherBiomet, Inc.20023—
+4K051069Nonresorbable Centraloc Tibial Screw & WasherArthrotek, Inc.20050—
+4K033233Lactosorb Tibial L-15 Screw and WasherBiomet, Inc.20032—
+5K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130—