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LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class II

FDA Device Classification

Classification Details

Product Code
LZO
Device Class
Class II
Regulation Number
888.3353
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252401implantcastimplaFit® short stemsMarch 12, 2026
K253171maxx orthopedicsLibertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)January 15, 2026
K250450medacta internationalCoated hip implantsSeptember 19, 2025
K243021signature orthopaedics ptyLongboard Revision Hip StemAugust 7, 2025
K251906zimmerZ1 Hip SystemJuly 18, 2025
K251292depuy ireland ucRECLAIM Monobloc Revision Femoral StemMay 23, 2025
K243927waldemar link gmbh and co. kgMobileLink Acetabular Cup System - inhouse coatingsMay 16, 2025
K250444microport orthopedicsNEXUS® Hip StemMay 15, 2025
K243043signature orthopaedics ptyOrigin™ Cemented Hip StemMay 2, 2025
K250834zimmer biometZimmer Biomet Ceramic Heads (22.2mm diameter)April 18, 2025
K250571smith and nephewCATALYSTEM Femoral StemsMarch 28, 2025
K243029signature orthopaedics ptyOrigin™ TT StemMarch 11, 2025
K241767medacta internationalVersacem Acetabular Shell and Double Mobility HC LinersMarch 6, 2025
K243809limacorporateBiolox® Delta Revision headsMarch 4, 2025
K241483encore medical, l.pceramys™ femoral head systemFebruary 7, 2025
K243466united orthopedic corporationConformity Stem Extension Line, #0January 6, 2025
K243444kyocera corporationBIOCERAM AZUL® HEADDecember 5, 2024
K240528b-one orthob-ONE® Total Hip SystemNovember 15, 2024
K240391implantcastMUTARS® femoral stem cemented 160 mm and 200 mmOctober 24, 2024
K242249united orthopedic corporationConformity Stem Extension LineAugust 30, 2024