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KWL — Prosthesis, Hip, Hemi-, Femoral, Metal Class II

FDA Device Classification

Classification Details

Product Code
KWL
Device Class
Class II
Regulation Number
888.3360
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253675osteoremediesOsteoRemedies Hip Spacer SystemDecember 23, 2025
K252326tecresInterSpace GV Hip SpacerAugust 6, 2025
K242865biocompositesSynicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerJune 12, 2025
K234028heraeus medicalCOPAL® exchange G hip spacer; COPAL® G+VFebruary 15, 2024
K222632howmedica osteonics corp., dba stryker orthopaedicsUHR Bipolar Implants, Restoration GAP II ImplantsOctober 21, 2022
K192995osteoremediesOsteoRemedies Hip Spacer SystemJanuary 10, 2020
K191981osteoremediesREMEDY Acetabular CupAugust 23, 2019
K172906osteoremediesREMEDY PLUS Hip Spacer, UNITE PLUS Bone CementAugust 29, 2018
K173967osteoremediesRemedy Acetabular CupFebruary 22, 2018
K143184signature orthopaedics ptyEvolve UniPolar HeadMarch 17, 2015
K112470mandell horwitz consultants2GC HIP/KNEE MODULAR SPACERApril 5, 2012
K101356tecresSpacer-G and Spacer-KSeptember 20, 2011
K111911corin usaCORIN OPTIMOM MODULAR HEADAugust 4, 2011
K062273tecresSPACER-G TEMPORARY HIP PROSTHESISMay 22, 2008
K071471howmedica osteonicsCORIN ADAPTOR SLEEVESeptember 10, 2007
K063791corin usaCORIN UNIPOLAR MODULAR HEADApril 3, 2007
K062408smith and nephewSMITH & NEPHEW MODULAR FEMORAL (HEMI) HEADSeptember 12, 2006
K061243smith and nephewSMITH & NEPHEW MODULAR FEMORAL HEADJuly 17, 2006
K042973ortho developmentSOLITUDE UNIPOLAR HEADJanuary 27, 2005
K031841exactechSPACER G TEMPORARY HIP PROSTHESISJanuary 22, 2004