PFC SIGMA Knee System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

DePuy Orthopaedics, Inc.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Pfc Sigma Knee System.

Pre-market Notification Details

Device IDK182301
501k NumberK182301
Device Name:PFC SIGMA Knee System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
ContactKathy Harris
CorrespondentBrian Kincaid
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-24
Decision Date2019-11-08

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