FDA.reportPublic FDA data

Bicompartmental knee prosthesis

Definition
A sterile implantable device designed to replace the patellofemoral and medial tibiofemoral articulating surfaces of a damaged/degenerative (e.g., arthritic) knee during primary or revision bicompartmental replacement of the joint; it is intended to permit retention of the lateral tibiofemoral compartment and both cruciate ligaments. The device is made of metal [e.g., oxidized zirconium alloy, cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; implantation is intended to be performed with bone cement.
GUDID devices
35
Last updated
2022-08-25 08:36:54

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M572BKA1111111021iDuo Conformis, Inc.BKA-111-1111022022-08-17
M572BKA1111111011iDuo® Bicompartmental Knee Replacement SystemConformis, Inc.BKA1111111012015-10-26
M572RBK1011112011iDuo® Femoral KitConformis, Inc.RBK1011112012015-10-26
M572RBK1011112021iDuo® Femoral KitConformis, Inc.RBK1011112022015-10-26
M572RBK1011113011iDuo® Tibial KitConformis, Inc.RBK1011113012015-10-26
M572RBK1011113021iDuo® Tibial KitConformis, Inc.RBK1011113022015-10-26
00885556030967LEGIONSmith & Nephew, Inc.714233282015-12-09
00885556107782LEGIONSmith & Nephew, Inc.714532362015-12-09
00885556107812LEGIONSmith & Nephew, Inc.714532262015-12-09
00885556107836LEGIONSmith & Nephew, Inc.714532162015-12-09
00885556107867LEGIONSmith & Nephew, Inc.714532062015-12-09
00885556108840LEGIONSmith & Nephew, Inc.714219332015-12-09
00885556108871LEGIONSmith & Nephew, Inc.714219062015-12-09
00885556109120LEGIONSmith & Nephew, Inc.714213062015-12-09
00811767024587FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RAUUX100-RK2015-10-07
00811767024594FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RAUUX200-RK2015-10-07
00811767024600FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RAUUX300-RK2015-10-07
00811767024617FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RAUUX400-RK2015-10-07
00811767024624FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RAUUX500-RK2015-10-07
00811767024631FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RAUUX600-RK2015-10-07
00811767024648FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RAUUX700-RK2015-10-07
00811767024655FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RAUUX800-RK2015-10-07
00811767024679FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RGPSDB00-RK2015-10-07
00811767024686FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RGPSDC00-RK2015-10-07
00811767024709FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RGPSDE00-RK2015-10-07
00811767024716FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RGPSDF00-RK2015-10-07
00811767024723FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RGPSDG00-RK2015-10-07
00811767024730FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RGPSDH00-RK2015-10-07
00811767024754FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RGPSPB00-RK2015-10-07
00811767024761FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RGPSPC00-RK2015-10-07
00811767024785FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RGPSPE00-RK2015-10-07
00811767024792FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RGPSPF00-RK2015-10-07
00811767024808FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RGPSPG00-RK2015-10-07
00811767024815FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RGPSPH00-RK2015-10-07
00811767024907FREEDOM STEMMEDMAXX ORTHOPEDICS, INC.RAUUX000-RK2015-10-07