510(k) Report

Devices descending from K001614

12 later devices reach Stryker Trauma Pelvic Set 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
+1K131132Pelvis II Implant SystemStryker Trauma AG20135—
+1K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+1K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+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—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—