510(k) Report

Devices descending from K021673

15 later devices reach Total Hip Femoral Head - 12/14 Taper through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc.20115—
+1K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+1K081566Smith & Nephew Oxinium DH Femoral HeadsSmith & Nephew, Inc.20088—
+1K023375Modification to Esop CO-CR Femoral HeadsPro-Active Healthcare20020—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+3K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—