510(k) Report

Devices descending from K980081

10 later devices reach S-Rom Zirconia Ceramic Femoral Hip Head through their predicates, nearest generation first.

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