JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class II

FDA Device Classification

Classification Details

Product Code
JDI
Device Class
Class II
Regulation Number
888.3350
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243571zimmer biometTrabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LJuly 31, 2025
K240783smith and nephewAnthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; SpectrOctober 21, 2024
K241716howmedica osteonics corp., dba stryker orthopaedicsGlobal Modular Replacement System, Modular Replacement System, Modular Rotating August 2, 2024
K240418howmedica osteonics corp., dba stryker orthopaedicsStryker Orthopaedics Hip Systems Labeling UpdateApril 12, 2024
K233261howmedica osteonics corp. a.k.a. stryker orthopaedicsGlobal Modular Replacement SystemDecember 8, 2023
K222056howmedica osteonics corp., dba stryker orthopaedicsGlobal Modular Replacement System, Modular Replacement System, Modular Rotating January 26, 2023
K220216depuy ireland ucC-Stem AMT LE ProsthesisJuly 22, 2022
K213701howmedica osteonics corp., dba stryker orthopaedicsExeter® X3® RimFit® CupFebruary 1, 2022
K213816microport orthopedicsMPO Hip InstrumentsJanuary 5, 2022
K210842zimmerVerSys Cemented Revision/CalcarDecember 10, 2021
K203815onkos surgicalELEOS Limb Salvage System with BioGripJune 9, 2021
K203588onkos surgicalELEOS™ Limb Salvage SystemFebruary 5, 2021
K203090onkos surgicalELEOS Limb Salvage System featuring BIOGRIPDecember 11, 2020
K201519microport orthopedicsPROFEMUR® GLADIATOR® Cemented Classic StemDecember 10, 2020
K193429howmedica osteonicsExeter V40 Femoral Stem, Exeter X3 RimFit CupAugust 13, 2020
K191449zimmerZCA All-Poly Acetabular CupsJuly 16, 2020
K200823zimmerZimmer, Inc. Hip Joint Prostheses MR Labeling IJuly 9, 2020
K191735zimmerCPT Hip SystemMarch 20, 2020
K191056united orthopedic corporationConformity stem, cementedJanuary 3, 2020
K191414stryker orthopaedicsEXETER Centralizer, EXETER 2.5mm PlugAugust 28, 2019