510(k) Report

Devices descending from K990261

9 later devices reach Plus Ceramic Head Prostheses (Alumina and Zirkonia) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K042035Alumina HeadFournitures Hospitalieres Industrie20041—
+1K012918Apex Modular Alumina Femoral HeadApex Surgical, LLC20017—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+2K050556Alumina HeadFournitures Hospitalieres Industrie20050—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K261576Icona Hip StemCorin, Ltd.20260—