510(k) Report

Devices descending from K881117

12 later devices reach Resubmitting of HJD Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K935921Zirconia Ceramic Femoral HeadSmith & Nephew Richards, Inc.199411—
+2K965002Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the…Encore Orthopedics, Inc.199710—
+3K990261Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics19999—
+4K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+4K042035Alumina HeadFournitures Hospitalieres Industrie20041—
+4K012918Apex Modular Alumina Femoral HeadApex Surgical, LLC20017—
+5K171156OMNI Anseris Hip StemOmnilife Science20170—
+5K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+5K050556Alumina HeadFournitures Hospitalieres Industrie20050—
+6K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+7K241472Icona Hip StemCorin U.S.A. Limited20241—
+8K261576Icona Hip StemCorin, Ltd.20260—