FDA.reportPublic FDA data

Coated knee tibia prosthesis

Definition
A sterile 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 of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) 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 may be performed with or without bone cement.
GUDID devices
1,065
Last updated
2026-06-13 06:05:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07613327041392TriathlonHowmedica Osteonics Corp.5527-B-1002015-09-24
07613327041408TriathlonHowmedica Osteonics Corp.5527-B-3002015-09-24
07613327041415TriathlonHowmedica Osteonics Corp.5527-B-2002015-09-24
07613327041422TriathlonHowmedica Osteonics Corp.5527-B-5002015-09-24
07613327041439TriathlonHowmedica Osteonics Corp.5527-B-4002015-09-24
07613327041446TriathlonHowmedica Osteonics Corp.5527-B-6002015-09-24
07613327041453TriathlonHowmedica Osteonics Corp.5527-B-7002015-09-24
07613327041460TriathlonHowmedica Osteonics Corp.5527-B-8002015-09-24
09348215014506Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 1 NarrowSIGNATURE ORTHOPAEDICS PTY LTD10-1513-04002026-05-18
09348215014513Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 1SIGNATURE ORTHOPAEDICS PTY LTD10-1513-04012026-05-18
09348215014520Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 2 NarrowSIGNATURE ORTHOPAEDICS PTY LTD10-1513-04022026-05-18
09348215014537Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 2SIGNATURE ORTHOPAEDICS PTY LTD10-1513-04032026-05-18
09348215014544Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 3 NarrowSIGNATURE ORTHOPAEDICS PTY LTD10-1513-04042026-05-18
09348215014551Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 3SIGNATURE ORTHOPAEDICS PTY LTD10-1513-04052026-05-18
09348215014568Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 4 NarrowSIGNATURE ORTHOPAEDICS PTY LTD10-1513-04062026-05-18
09348215014575Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 4SIGNATURE ORTHOPAEDICS PTY LTD10-1513-04072026-05-18
09348215014582Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 5SIGNATURE ORTHOPAEDICS PTY LTD10-1513-04082026-05-18
09348215157296Active-V Knee Cementless Tibial Modular Tray - 80mm Finned Keel - Size 1 NarrowSIGNATURE ORTHOPAEDICS PTY LTD10-1513-04102026-05-18
09348215157302Active-V Knee Cementless Tibial Modular Tray - 80mm Finned Keel - Size 1SIGNATURE ORTHOPAEDICS PTY LTD10-1513-04112026-05-18
09348215157319Active-V Knee Cementless Tibial Modular Tray - 80mm Finned Keel - Size 2 NarrowSIGNATURE ORTHOPAEDICS PTY LTD10-1513-04122026-05-18
09348215157326Active-V Knee Cementless Tibial Modular Tray - 80mm Finned Keel - Size 2SIGNATURE ORTHOPAEDICS PTY LTD10-1513-04132026-05-18
09348215157333Active-V Knee Cementless Tibial Modular Tray - 80mm Finned Keel - Size 3 NarrowSIGNATURE ORTHOPAEDICS PTY LTD10-1513-04142026-05-18
09348215157340Active-V Knee Cementless Tibial Modular Tray - 80mm Finned Keel - Size 3SIGNATURE ORTHOPAEDICS PTY LTD10-1513-04152026-05-18
09348215157357Active-V Knee Cementless Tibial Modular Tray - 80mm Finned Keel - Size 4 NarrowSIGNATURE ORTHOPAEDICS PTY LTD10-1513-04162026-05-18
09348215157364Active-V Knee Cementless Tibial Modular Tray - 80mm Finned Keel - Size 4SIGNATURE ORTHOPAEDICS PTY LTD10-1513-04172026-05-18
09348215157371Active-V Knee Cementless Tibial Modular Tray - 80mm Finned Keel - Size 5SIGNATURE ORTHOPAEDICS PTY LTD10-1513-04182026-05-18
09348215157463Active-V Knee Cemented Tibial Modular Tray - 40mm Finned Keel - Size 5SIGNATURE ORTHOPAEDICS PTY LTD10-1513-04282026-05-18
10603295008354NADEPUY ORTHOPAEDICS, INC.1188-30-002015-09-24
10603295073994AMKDEPUY ORTHOPAEDICS, INC.1888-78-0002015-12-18
10603295249986P.F.C. SIGMADEPUY ORTHOPAEDICS, INC.96-75042015-09-24
10603295249993P.F.C. SIGMADEPUY ORTHOPAEDICS, INC.96-75052015-09-24
10603295250005P.F.C. SIGMADEPUY ORTHOPAEDICS, INC.96-75062015-09-24
10603295250012P.F.C. SIGMADEPUY ORTHOPAEDICS, INC.96-75072015-09-24
10603295250029P.F.C. SIGMADEPUY ORTHOPAEDICS, INC.96-75082015-09-24
10603295250036P.F.C. SIGMADEPUY ORTHOPAEDICS, INC.96-75092015-09-24
10603295250043P.F.C. SIGMADEPUY ORTHOPAEDICS, INC.96-75102015-09-24
M209102460TRAY TOTAL 62BIOPRO, INC.102462015-09-16
M209102470TRAY TOTAL 66BIOPRO, INC.102472015-09-16
M209102480TRAY TOTAL 70BIOPRO, INC.102482015-09-16
M209102490TRAY TOTAL 74BIOPRO, INC.102492015-09-16
M209102500TRAY TOTAL 78BIOPRO, INC.102502015-09-16
M209102510TRAY TOTAL 82BIOPRO, INC.102512015-09-16
M209102520TRAY TOTAL 86BIOPRO, INC.102522015-09-16
M209103240PLUG MOD TRAYBIOPRO, INC.103242015-09-16
M209103250TRAY MOD 62BIOPRO, INC.103252015-09-16
M209103260TRAY MOD 66BIOPRO, INC.103262015-09-16
M209103270TRAY MOD 70BIOPRO, INC.103272015-09-16
M209103280TRAY MOD 74BIOPRO, INC.103282015-09-16
M209103290TRAY MOD 78BIOPRO, INC.103292015-09-16
M209103300TRAY MOD 82BIOPRO, INC.103302015-09-16
M209103310TRAY MOD 86BIOPRO, INC.103312015-09-16
M209103390ROD TIBIAL MEDULLARY 9X50BIOPRO, INC.103392015-09-16
M209103400ROD TIBIAL MEDULLARY 9X150BIOPRO, INC.103402015-09-16
M209103410ROD TIBIAL MEDULLARY 10X50BIOPRO, INC.103412015-09-16
M209103420ROD TIBIAL MEDULLARY 10X150BIOPRO, INC.103422015-09-16
M209103500ROD TIBIAL MEDULLARY 11X50BIOPRO, INC.103502015-09-16
M209103510ROD TIBIAL MEDULLARY 11X150BIOPRO, INC.103512015-09-16
M209103520ROD TIBIAL MEDULLARY 12X50BIOPRO, INC.103522015-09-16
M209103530ROD TIBIAL MEDULLARY 12X150BIOPRO, INC.103532015-09-16
M209103540ROD TIBIAL MEDULLARY 13X50BIOPRO, INC.103542015-09-06
M209103550ROD TIBIAL MEDULLARY 13X150BIOPRO, INC.103552015-09-16
M209103630ROD TIBIAL MEDULLARY 14X50BIOPRO, INC.103632015-09-16
M209103640ROD TIBIAL MEDULLARY 14X150BIOPRO, INC.103642015-09-16
M209103650ROD TIBIAL MEDULLARY 15X50BIOPRO, INC.103652015-09-16
M209103660ROD TIBIAL MEDULLARY 15X150BIOPRO, INC.103662015-09-16
M68415760065001AXIOM® Microport Orthopedics Inc.15760065002015-10-22
M68415760070001AXIOM® Microport Orthopedics Inc.15760070002015-10-22
M68415760075001AXIOM® Microport Orthopedics Inc.15760075002015-10-22
M68415760080001AXIOM® Microport Orthopedics Inc.15760080002015-10-22
M68415760085001AXIOM® Microport Orthopedics Inc.15760085002015-10-22
M684187261001ADVANTIM®Microport Orthopedics Inc.187261002015-10-23
M684187261021ADVANTIM®Microport Orthopedics Inc.187261022015-10-23
M684187261041ADVANTIM®Microport Orthopedics Inc.187261042015-10-23
M684187262001ADVANTIM®Microport Orthopedics Inc.187262002015-10-23
M684187262021ADVANTIM®Microport Orthopedics Inc.187262022015-10-23
M684187263001ADVANTIM®Microport Orthopedics Inc.187263002015-10-23
M684187263021ADVANTIM®Microport Orthopedics Inc.187263022015-10-23
M684187271001ADVANTIM®Microport Orthopedics Inc.187271002015-10-23
M684187271021ADVANTIM®Microport Orthopedics Inc.187271022015-10-23
M684187272001ADVANTIM®Microport Orthopedics Inc.187272002015-10-23