510(k) Report

Devices descending from K000575

307 later devices reach Global Advantage Extended Humeral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+8K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+10K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—