FDA.report

Product code LPH

Current FDA Classification

Device name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3358
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
K252623G7® Revision Acetabular SystemZimmer, Inc.2026-02-04
K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.2026-01-28
K252067Velora Acetabular SystemRestor3D, Inc.2025-12-05
K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics2025-11-20
K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.2025-11-12
K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A.2025-08-29
K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)2025-07-25
K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.2025-06-06
K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited2025-06-05
K242232Mpact 3D Metal Augments IIMedacta International S.A.2025-04-23
K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.2025-04-10
K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-02-06
K243977EMPHASYS Acetabular SystemDepuy Ireland UC2025-01-22
K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A2025-01-13
K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG2024-11-08
K242833Legend® Acetabular ShellOrtho Development Corp.2024-10-11
K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.2024-10-07
K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC2024-10-07
K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics2024-04-18
K231522EMPHASYS™ Dual Mobility SystemDepuy Ireland UC2024-02-15
K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023-12-21
K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.2023-10-27
K232556DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup SystemDepuy Ireland UC2023-09-20
K230011Mpact ExtensionMedacta International S.A.2023-09-20
K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt. , Ltd.2023-05-09
K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG2023-04-14
K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.2023-02-27
K223779EMPOWR™ blade stemEncore Medical, LLC2023-02-13
K223348My3D® Personalized Pelvic ReconstructionOnkos Surgical, Inc.2023-01-30
K211047CoCr HeadZimmer GmbH2023-01-10

Related GUDID Devices

Primary DIBrandCompanyPublished
10885862660633N/AExactech, Inc.2026-03-19
04580810068668Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068828Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068811Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068804Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068798Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
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04580810068774Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068767Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068750Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068743Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068736Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068729Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068712Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068705Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068699Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068620Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068422Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068385Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068194Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068187Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068170Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810068163Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810067869Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810067845Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810067821Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810067807Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810067784Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810066909Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27
04580810066831Initia Total Hip SystemKYOCERA MEDICAL CORPORATION2026-02-27