Product code LZO

Current FDA Classification

Device name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3353
Review panel
OR
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.2026-04-27
K260037implantcast Packaging System UpdateImplantcast GmbH2026-03-30
K252401implaFit® short stemsImplantcast GmbH2026-03-12
K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.2026-01-15
K250450Coated hip implantsMedacta International S.A.2025-09-19
K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.2025-08-07
K251906Z1 Hip SystemZimmer, Inc.2025-07-18
K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC2025-05-23
K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG2025-05-16
K250444NEXUS® Hip StemMicroport Orthopedics, Inc.2025-05-15
K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.2025-05-02
K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet2025-04-18
K250571CATALYSTEM Femoral StemsSmith & Nephew, Inc.2025-03-28
K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.2025-03-11
K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.2025-03-06
K243809Biolox® Delta Revision headsLimacorporate2025-03-04
K241483ceramys™ femoral head systemEncore Medical L.P.2025-02-07
K243466Conformity Stem Extension Line, #0United Orthopedic Corporation2025-01-06
K243444BIOCERAM AZUL® HEADKyocera Corporation2024-12-05
K240528b-ONE® Total Hip SystemB-One Ortho, Corp.2024-11-15
K240391MUTARS® femoral stem cemented 160 mm and 200 mmImplantcast GmbH2024-10-24
K242249Conformity Stem Extension LineUnited Orthopedic Corporation2024-08-30
K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC2024-08-27
K240381CATALYSTEM Femoral StemsSmith & Nephew, Inc.2024-06-27
K240834EcoFit® short stem cementless cpTiImplantcast GmbH2024-06-03
K23402522.2mm BIOLOX® delta Ceramic V40™ Femoral HeadsHowmedica Osteonics Corp., Dba Stryker Orthopaedics2024-04-24
K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.2024-04-12
K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics2024-03-11
K233476Z1 Hip SystemOrchard Medical Development2024-02-08
K223745Novae® Dual Mobility System, Hype® Hip SystemSerf2023-12-22

Related GUDID Devices

Primary DIBrandCompanyPublished
04048844732042implaFit®implantcast GmbH2026-03-20
04048844732059implaFit®implantcast GmbH2026-03-20
04048844732080implaFit®implantcast GmbH2026-03-20
04048844732097implaFit®implantcast GmbH2026-03-20
04048844731977implaFit®implantcast GmbH2026-03-20
10885862660275N/AExactech, Inc.2026-03-19
10885862660381N/AExactech, Inc.2026-03-19
10885862660282N/AExactech, Inc.2026-03-19
10885862660299N/AExactech, Inc.2026-03-19
10885862660305N/AExactech, Inc.2026-03-19
10885862660312N/AExactech, Inc.2026-03-19
10885862660329N/AExactech, Inc.2026-03-19
10885862660336N/AExactech, Inc.2026-03-19
10885862660343N/AExactech, Inc.2026-03-19
10885862660350N/AExactech, Inc.2026-03-19
10885862660367N/AExactech, Inc.2026-03-19
10885862660374N/AExactech, Inc.2026-03-19
10885862660268N/AExactech, Inc.2026-03-19
10885862660251N/AExactech, Inc.2026-03-19
10885862660244N/AExactech, Inc.2026-03-19
10885862660237N/AExactech, Inc.2026-03-19
10885862660220N/AExactech, Inc.2026-03-19
10885862660213N/AExactech, Inc.2026-03-19
10885862660206N/AExactech, Inc.2026-03-19
10885862660190N/AExactech, Inc.2026-03-19
10885862660183N/AExactech, Inc.2026-03-19
10885862660176N/AExactech, Inc.2026-03-19
10885862660169N/AExactech, Inc.2026-03-19
10885862660152N/AExactech, Inc.2026-03-19
10885862660145N/AExactech, Inc.2026-03-19