FDA.report

510(k) K251292

Device
RECLAIM Monobloc Revision Femoral Stem
Applicant
Depuy Ireland UC
510(k) number
K251292
Product code
LZO
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-23
Date received
2025-04-25
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
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Robin Layton
Address
Loughbeg Ringaskiddy Cork IE

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code LZO

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
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