FDA.reportPublic FDA data

Uncoated knee tibia prosthesis, polyethylene

Definition
An implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made entirely of polyethylene (PE) and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.
GUDID devices
5,293
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810008125731FreedomMAXX ORTHOPEDICS, INC.ALCRXB109-K2022-12-08
00810008125748FreedomMAXX ORTHOPEDICS, INC.ALCRXB111-K2022-12-08
00810008125755FreedomMAXX ORTHOPEDICS, INC.ALCRXB114-K2022-12-08
00810008125762FreedomMAXX ORTHOPEDICS, INC.ALCRXB117-K2023-01-30
00810008125779FreedomMAXX ORTHOPEDICS, INC.ALCRXC409-K2022-12-08
00810008125786FreedomMAXX ORTHOPEDICS, INC.ALCRXC411-K2022-12-08
00810008125793FreedomMAXX ORTHOPEDICS, INC.ALCRXC414-K2022-12-08
00810008125809FreedomMAXX ORTHOPEDICS, INC.ALCRXC417-K2022-12-08
00810008125816FreedomMAXX ORTHOPEDICS, INC.ALCRXE309-K2022-12-08
00810008125823FreedomMAXX ORTHOPEDICS, INC.ALCRXE311-K2022-12-08
00810008125830FreedomMAXX ORTHOPEDICS, INC.ALCRXE314-K2022-12-08
00810008125847FreedomMAXX ORTHOPEDICS, INC.ALCRXE317-K2022-12-08
00810008125854FreedomMAXX ORTHOPEDICS, INC.ALCRXE609-K2022-12-08
00810008125861FreedomMAXX ORTHOPEDICS, INC.ALCRXE611-K2022-12-08
00810008125878FreedomMAXX ORTHOPEDICS, INC.ALCRXE614-K2023-01-30
00810008125885FreedomMAXX ORTHOPEDICS, INC.ALCRXE617-K2022-12-08
00810008125892FreedomMAXX ORTHOPEDICS, INC.ALCRXF609-K2022-12-08
00810008125908FreedomMAXX ORTHOPEDICS, INC.ALCRXF611-K2022-12-08
00810008125915FreedomMAXX ORTHOPEDICS, INC.ALCRXF614-K2023-01-30
00810008125922FreedomMAXX ORTHOPEDICS, INC.ALCRXF617-K2022-12-08
00810008125939FreedomMAXX ORTHOPEDICS, INC.ALCRXF709-K2022-12-08
00810008125946FreedomMAXX ORTHOPEDICS, INC.ALCRXF711-K2022-12-08
00810008125953FreedomMAXX ORTHOPEDICS, INC.ALCRXF714-K2022-12-08
00810008125960FreedomMAXX ORTHOPEDICS, INC.ALCRXF717-K2022-12-08
00810008125977FreedomMAXX ORTHOPEDICS, INC.ALCRXG509-K2023-01-30
00810008125984FreedomMAXX ORTHOPEDICS, INC.ALCRXG511-K2022-12-08
00810008125991FreedomMAXX ORTHOPEDICS, INC.ALCRXG514-K2022-12-08
00810008126004FreedomMAXX ORTHOPEDICS, INC.ALCRXG517-K2022-12-08
00810008126011FreedomMAXX ORTHOPEDICS, INC.ALCRXG609-K2023-01-30
00810008126028FreedomMAXX ORTHOPEDICS, INC.ALCRXG611-K2022-12-08
00810008126035FreedomMAXX ORTHOPEDICS, INC.ALCRXG614-K2022-12-08
00810008126042FreedomMAXX ORTHOPEDICS, INC.ALCRXG617-K2022-12-08
00810008126059FreedomMAXX ORTHOPEDICS, INC.ALCRXG809-K2022-12-08
00810008126066FreedomMAXX ORTHOPEDICS, INC.ALCRXG811-K2022-12-08
00810008126073FreedomMAXX ORTHOPEDICS, INC.ALCRXG814-K2022-12-08
00810008126080FreedomMAXX ORTHOPEDICS, INC.ALCRXG817-K2023-01-30
00810008126097FreedomMAXX ORTHOPEDICS, INC.ALCRXH809-K2022-12-08
00810008126103FreedomMAXX ORTHOPEDICS, INC.ALCRXH811-K2023-01-30
00810008126110FreedomMAXX ORTHOPEDICS, INC.ALCRXH814-K2022-12-08
00810008126127FreedomMAXX ORTHOPEDICS, INC.ALCRXH817-K2023-01-30
00810008126134FreedomMAXX ORTHOPEDICS, INC.ALPSXB109-K2022-12-08
00810008126141FreedomMAXX ORTHOPEDICS, INC.ALPSXB111-K2022-12-08
00810008126158FreedomMAXX ORTHOPEDICS, INC.ALPSXB114-K2022-12-08
00810008126165FreedomMAXX ORTHOPEDICS, INC.ALPSXB117-K2022-12-08
00810008126172FreedomMAXX ORTHOPEDICS, INC.ALPSXC409-K2022-12-08
00810008126189FreedomMAXX ORTHOPEDICS, INC.ALPSXC411-K2022-12-08
00810008126196FreedomMAXX ORTHOPEDICS, INC.ALPSXC414-K2022-12-08
00810008126202FreedomMAXX ORTHOPEDICS, INC.ALPSXC417-K2022-12-08
00810008126219FreedomMAXX ORTHOPEDICS, INC.ALPSXE309-K2022-12-08
00810008126226FreedomMAXX ORTHOPEDICS, INC.ALPSXE311-K2022-12-08
00810008126233FreedomMAXX ORTHOPEDICS, INC.ALPSXE314-K2022-12-08
00810008126240FreedomMAXX ORTHOPEDICS, INC.ALPSXE317-K2023-01-30
00810008126257FreedomMAXX ORTHOPEDICS, INC.ALPSXE609-K2023-01-30
00810008126264FreedomMAXX ORTHOPEDICS, INC.ALPSXE611-K2022-12-08
00810008126271FreedomMAXX ORTHOPEDICS, INC.ALPSXE614-K2022-12-08
00810008126288FreedomMAXX ORTHOPEDICS, INC.ALPSXE617-K2023-01-30
00810008126295FreedomMAXX ORTHOPEDICS, INC.ALPSXF609-K2023-01-30
00810008126301FreedomMAXX ORTHOPEDICS, INC.ALPSXF611-K2022-12-08
00810008126318FreedomMAXX ORTHOPEDICS, INC.ALPSXF614-K2022-12-08
00810008126325FreedomMAXX ORTHOPEDICS, INC.ALPSXF617-K2022-12-08
00810008126332FreedomMAXX ORTHOPEDICS, INC.ALPSXF709-K2023-01-30
00810008126349FreedomMAXX ORTHOPEDICS, INC.ALPSXF711-K2023-01-30
00810008126356FreedomMAXX ORTHOPEDICS, INC.ALPSXF714-K2022-12-08
00810008126363FreedomMAXX ORTHOPEDICS, INC.ALPSXF717-K2022-12-08
00810008126370FreedomMAXX ORTHOPEDICS, INC.ALPSXG509-K2023-01-30
00810008126387FreedomMAXX ORTHOPEDICS, INC.ALPSXG511-K2023-01-30
00810008126394FreedomMAXX ORTHOPEDICS, INC.ALPSXG514-K2023-01-30
00810008126400FreedomMAXX ORTHOPEDICS, INC.ALPSXG517-K2022-12-08
00810008126417FreedomMAXX ORTHOPEDICS, INC.ALPSXG609-K2022-12-08
00810008126424FreedomMAXX ORTHOPEDICS, INC.ALPSXG611-K2022-12-08
00810008126431FreedomMAXX ORTHOPEDICS, INC.ALPSXG614-K2023-01-30
00810008126448FreedomMAXX ORTHOPEDICS, INC.ALPSXG617-K2022-12-08
00810008126455FreedomMAXX ORTHOPEDICS, INC.ALPSXG809-K2022-12-08
00810008126462FreedomMAXX ORTHOPEDICS, INC.ALPSXG811-K2023-01-30
00810008126479FreedomMAXX ORTHOPEDICS, INC.ALPSXG814-K2022-12-08
00810008126486FreedomMAXX ORTHOPEDICS, INC.ALPSXG817-K2022-12-08
00810008126493FreedomMAXX ORTHOPEDICS, INC.ALPSXH809-K2022-12-08
00810008126509FreedomMAXX ORTHOPEDICS, INC.ALPSXH811-K2022-12-08
00810008126516FreedomMAXX ORTHOPEDICS, INC.ALPSXH814-K2022-12-08
00810008126523FreedomMAXX ORTHOPEDICS, INC.ALPSXH817-K2022-12-08