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KRR — Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Class II

FDA Device Classification

Classification Details

Product Code
KRR
Device Class
Class II
Regulation Number
888.3540
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231253overture resurfacingOverture Orthopaedics Patellofemoral SystemJuly 7, 2023
K221048episurf medicalEpisealer Patellofemoral SystemDecember 23, 2022
K211303howmedica osteonics corp., dba stryker orthopaedicsAvon Patello-femoral Joint ProsthesisJune 4, 2021
K200122medacta internationalMOTO PFJ SystemApril 20, 2020
K181280arthrosurfacePatello-Femoral Wave (Kahuna) Arthroplasty SystemJune 14, 2018
K160461arthrexArthrex iBalance BiCompartmental Arthroplasty SystemApril 12, 2016
K143543biometPrelude PF PatellaeJanuary 30, 2015
K123907biomet manufacturingPRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST September 3, 2013
K111970tornierKNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENTFebruary 23, 2012
K082088mako surgicalMAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM IIOctober 22, 2008
K080029mako surgicalMAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEMMay 16, 2008
K073120accelerated innovationACCIN PATELLOFEMORAL SYSTEMFebruary 29, 2008
K071413arthrosurfaceHEMICAP PATELLO-FEMORAL RESURFACING SYSTEMNovember 9, 2007
K070695zimmerZIMMER PATELLOFEMORAL JOINT PROSTHESISJune 7, 2007
K060127arthrosurfaceHEMICAP PATELLO-FEMORAL RESURFACING PROSTHESISMarch 16, 2006
K050473global orthopaedic technology, usaRBK PATELLA FEMORAL KNEENovember 14, 2005
K051948howmedica osteonicsAVON PATELLO-FEMORAL JOINT PROSTHESISOctober 21, 2005
K051086smith and nephewSMITH & NEPHEW PATELLO-FEMORAL IMPLANTMay 31, 2005
K041160howmedica osteonicsAVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENTMay 27, 2004
K013982kinamedKINEMATCH PATELLO-FEMORAL RESURFACING IMPALANTMay 21, 2002