510(k) Report

Devices descending from K926395

11 later devices reach Elite (TM) Zirconia Total Hip Ball Head System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K965002Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the…Encore Orthopedics, Inc.199710—
+2K990261Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics19999—
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K042035Alumina HeadFournitures Hospitalieres Industrie20041—
+3K012918Apex Modular Alumina Femoral HeadApex Surgical, LLC20017—
+4K171156OMNI Anseris Hip StemOmnilife Science20170—
+4K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+4K050556Alumina HeadFournitures Hospitalieres Industrie20050—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+7K261576Icona Hip StemCorin, Ltd.20260—