FDA.reportPublic FDA data

510(k) K252824

Device
Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
Applicant
Signature Orthopaedics Pty, Ltd.
510(k) number
K252824
Product code
JDI
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-12
Date received
2025-09-05
Regulation
888.3350
Classification name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Declan Brazil
Address
7 Sirius Rd. Lane Cove West AU 2066 2066

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JDI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.2026-07-01
K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet2025-07-31
K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.2024-10-21
K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics2024-08-02
K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2024-04-12
K233261Global Modular Replacement SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2023-12-08
K222056Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-26
K220216C-Stem AMT LE ProsthesisDepuy Ireland UC2022-07-22
K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics2022-02-01
K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.2022-01-05
K210842VerSys Cemented Revision/CalcarZimmer, Inc.2021-12-10
K203815ELEOS Limb Salvage System with BioGripOnkos Surgical2021-06-09
K203588ELEOS™ Limb Salvage SystemOnkos Surgical2021-02-05
K203090ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical2020-12-11
K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.2020-12-10