510(k) Report

Devices descending from K131132

5 later devices reach Pelvis II Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223772PRO Plating System, Stryker Trauma Pelvic Set (Matta)Stryker GmbH20231—
+1K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+2K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—