510(k) Report

Devices descending from K051995

12 later devices reach Profemur Renaissance Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+1K130984Profemur Renaissance Classic Hip StemWrightmedicaltechnologyinc20134—
+1K072817Echelon Titanium Hip SystemSmith & Nephew, Inc.20086—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+2K141235Profemur Renaissance Classic Long Neck Hip StemsMicroport Orthopedics, Inc.20143—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc.20115—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+3K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—