510(k) Report

Devices descending from K974685

29 later devices reach Osteonics Polyethylene Acetabular Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+1K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+1K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+1K993352Crossfire System 12 Acetabular InsertsHowmedica Osteonics Corp.199918—
+2K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+2K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+2K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+2K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+2K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+2K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+3K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+3K243444Bioceram Azul® HeadKyocera Corporation20240—
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K211866Bencox THR SystemCorentec Co., Ltd.20210—
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—