FDA.reportPublic FDA data

510(k) K243029

Device
Origin? TT Stem
Applicant
Signature Orthopaedics Pty, Ltd.
510(k) number
K243029
Product code
LZO
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-11
Date received
2024-09-27
Regulation
888.3353
Classification name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

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 LZO#

510(k), Device, Applicant table
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
K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.2025-03-06
K243809Biolox® Delta Revision headsLimacorporate2025-03-04