510(k) Report

Devices descending from K955306

15 later devices reach Omega+ Compression Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc.19993—
+1K971993Odi Compression Hip Screw SystemOrthopaedic Designs, Inc.19970—
+1K970258Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck…Ferguson Medical19978—
+1K970280Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam…Ferguson Medical19970—
+2K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi)20042—
+2K022139Hip Tool ImplantOrthopedic Sciences, Inc.20027—
+3K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc.20111—
+3K063709TS-Bone Hip ToolOrthopedic Sciences, Inc.20071—
+3K052538S-Bone Hip ToolOrthopedic Sciences, Inc.20050—
+3K051032Titanium-Hip ToolOrthopedic Sciences, Inc.20050—
+3K051181Custom-Hip ToolOrthopedic Sciences, Inc.20050—
+3K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc.20041—
+4K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+4K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc.20070—
+4K063033Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc.20060—