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NPJ — Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class II

FDA Device Classification

Classification Details

Product Code
NPJ
Device Class
Class II
Regulation Number
888.3560
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K150307mako surgicalRESTORIS Multicompartmental Knee SystemMarch 10, 2015
K133039mako surgical corporationRESTORIS MULTICOMPARTMENTAL KNEE SYSTEMDecember 10, 2013
K093513conformisIDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMDecember 16, 2009
K093056smith and nephewSMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEMDecember 15, 2009
K090763mako surgical corporationRESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMJune 17, 2009
K070849depuy orthopaedicsDEPUY GCK FEMORAL AND TIBIAL COMPONENTSJune 26, 2007
K061648depuy orthopaedicsDEPUY GRADUATED COMPARTMENTAL KNEE (GCK)September 11, 2006
K061569smith and nephewSMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTSJuly 6, 2006
K053488conformisCONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEMMarch 9, 2006
K052917howmedica osteonicsSTRYKER COMPARTMENTAL KNEE SYSTEMDecember 27, 2005
K052265smith and nephewSMITH & NEPHEW COMPETITOR DUO KNEE FEMORALDecember 27, 2005
K042896smith and nephewSMITH & NEPHEW HYBRID KNEE FEMORALJanuary 12, 2005