FDA.reportPublic FDA data

Uncoated knee tibia prosthesis, metallic

Definition
An implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] 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/or the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.
GUDID devices
3,934
Last updated
2026-09-29 04:02:17

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00192629082854EVOLUTIONMicroport Orthopedics Inc.ETPKN1SL2026-09-18
00192629082861EVOLUTIONMicroport Orthopedics Inc.ETPKN2SL2026-09-18
00192629082878EVOLUTIONMicroport Orthopedics Inc.ETPKN2PL2026-09-18
00192629082885EVOLUTIONMicroport Orthopedics Inc.ETPKN3SL2026-09-18
00192629082892EVOLUTIONMicroport Orthopedics Inc.ETPKN4SL2026-09-18
00192629082908EVOLUTIONMicroport Orthopedics Inc.ETPKN5SL2026-09-18
00192629082915EVOLUTIONMicroport Orthopedics Inc.ETPKN6SL2026-09-18
00192629082922EVOLUTIONMicroport Orthopedics Inc.ETPKN6PL2026-09-18
00192629082939EVOLUTIONMicroport Orthopedics Inc.ETPKN7SL2026-09-18
00192629082946EVOLUTIONMicroport Orthopedics Inc.ETPKN8SL2026-09-18
00192629082953EVOLUTIONMicroport Orthopedics Inc.ETPKN8PL2026-09-18
00192629082960EVOLUTIONMicroport Orthopedics Inc.ETPKN1SR2026-09-18
00192629082977EVOLUTIONMicroport Orthopedics Inc.ETPKN2SR2026-09-18
00192629082984EVOLUTIONMicroport Orthopedics Inc.ETPKN2PR2026-09-18
00192629082991EVOLUTIONMicroport Orthopedics Inc.ETPKN3SR2026-09-18
00192629083004EVOLUTIONMicroport Orthopedics Inc.ETPKN4SR2026-09-18
00192629083011EVOLUTIONMicroport Orthopedics Inc.ETPKN5SR2026-09-18
00192629083028EVOLUTIONMicroport Orthopedics Inc.ETPKN6SR2026-09-18
00192629083035EVOLUTIONMicroport Orthopedics Inc.ETPKN6PR2026-09-18
00192629083042EVOLUTIONMicroport Orthopedics Inc.ETPKN8PR2026-09-18
00192629083912EVOLUTIONMicroport Orthopedics Inc.ETPKN7SR2026-09-18
00192629083929EVOLUTIONMicroport Orthopedics Inc.ETPKN8SR2026-09-18
00193982677428ACTIFY 3DGLOBUS MEDICAL, INC.1232.4550S2026-08-14
00193982677435ACTIFY 3DGLOBUS MEDICAL, INC.1232.5545S2026-08-14
00193982677442ACTIFY 3DGLOBUS MEDICAL, INC.1232.5550S2026-08-14
00193982677459ACTIFY 3DGLOBUS MEDICAL, INC.1232.5560S2026-08-14
03701089518390TRAXAMPLITUDE SAS1-02089002026-07-29
03701089518406TRAXAMPLITUDE SAS1-02089012026-07-29
03701089518413TRAXAMPLITUDE SAS1-02089022026-07-29
03701089518420TRAXAMPLITUDE SAS1-02089032026-07-29
03701089518437TRAXAMPLITUDE SAS1-02089042026-07-29
03701089518444TRAXAMPLITUDE SAS1-02089052026-07-29
03701089518451TRAXAMPLITUDE SAS1-02089062026-07-29
03701089518468TRAXAMPLITUDE SAS1-02089072026-07-29
03701089518475TRAXAMPLITUDE SAS1-02089082026-07-29
03701089518482TRAXAMPLITUDE SAS1-02090002026-07-29
03701089518499TRAXAMPLITUDE SAS1-02090012026-07-29
03701089518505TRAXAMPLITUDE SAS1-02090022026-07-29
03701089518512TRAXAMPLITUDE SAS1-02090032026-07-29
03701089518529TRAXAMPLITUDE SAS1-02090042026-07-29
03701089518536TRAXAMPLITUDE SAS1-02090052026-07-29
03701089518543TRAXAMPLITUDE SAS1-02090062026-07-29
03701089518550TRAXAMPLITUDE SAS1-02090072026-07-29
03701089518567TRAXAMPLITUDE SAS1-02090082026-07-29
08800017260853EXULT Knee Replacement SystemCorentec Co., LtdK3.BFN.36572020-01-10
08800017260860EXULT Knee Replacement SystemCorentec Co., LtdK3.BFN.38602020-01-10
08800017260877EXULT Knee Replacement SystemCorentec Co., LtdK3.BFN.40632020-01-10
08800017260884EXULT Knee Replacement SystemCorentec Co., LtdK3.BFN.42662020-01-10
08800017260891EXULT Knee Replacement SystemCorentec Co., LtdK3.BFN.44692020-01-10
08800017260907EXULT Knee Replacement SystemCorentec Co., LtdK3.BFN.45722020-01-10
08800017260914EXULT Knee Replacement SystemCorentec Co., LtdK3.BFN.47752020-01-10
08800017260921EXULT Knee Replacement SystemCorentec Co., LtdK3.BFN.50792020-01-10
08800017260938EXULT Knee Replacement SystemCorentec Co., LtdK3.BFN.53832020-01-10
08800017260945EXULT Knee Replacement SystemCorentec Co., LtdK3.BFN.57862020-01-10
08800017260952EXULT Knee Replacement SystemCorentec Co., LtdK3.BFU.36572020-01-10
08800017260969EXULT Knee Replacement SystemCorentec Co., LtdK3.BFU.38602020-01-10
08800017260976EXULT Knee Replacement SystemCorentec Co., LtdK3.BFU.40632020-01-10
08800017260983EXULT Knee Replacement SystemCorentec Co., LtdK3.BFU.42662020-01-10
08800017260990EXULT Knee Replacement SystemCorentec Co., LtdK3.BFU.44692020-01-10
08800017261003EXULT Knee Replacement SystemCorentec Co., LtdK3.BFU.45722020-01-10
08800017261010EXULT Knee Replacement SystemCorentec Co., LtdK3.BFU.47752020-01-10
08800017261027EXULT Knee Replacement SystemCorentec Co., LtdK3.BFU.50792020-01-10
08800017261034EXULT Knee Replacement SystemCorentec Co., LtdK3.BFU.53832020-01-10
08800017261041EXULT Knee Replacement SystemCorentec Co., LtdK3.BFU.57862020-01-10
00888867106697Arthrex®ARTHREX, INC.AR-503-TTTB2017-02-15
09348215046019World Knee Cemented Titanium Tibial Plate - Modular - Size 1 - 40mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-41202026-06-26
09348215046026World Knee Cemented Titanium Tibial Plate - Modular - Size 2 - 40mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-42202026-06-26
09348215046033World Knee Cemented Titanium Tibial Plate - Modular - Size 3 - 40mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-43202026-06-26
09348215046040World Knee Cemented Titanium Tibial Plate - Modular - Size 4 - 40mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-44202026-06-26
09348215046057World Knee Cemented Titanium Tibial Plate - Modular - Size 5 - 40mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-45202026-06-26
09348215046064World Knee Cemented Titanium Tibial Plate - Modular - Size 6 - 40mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-46202026-06-26
09348215046071World Knee Cemented Titanium Tibial Plate - Modular - Size 7 - 40mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-47202026-06-26
09348215046088World Knee Cemented Titanium Tibial Plate - Modular - Size 8 - 40mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-48202026-06-26
09348215046095World Knee Cemented Titanium Tibial Plate - Modular - Size 9 - 40mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-49202026-06-26
09348215161347World Knee Cemented Titanium Tibial Plate - Modular - Size 1 - 80mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-41212026-06-26
09348215161354World Knee Cemented Titanium Tibial Plate - Modular - Size 2 - 80mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-42212026-06-26
09348215161361World Knee Cemented Titanium Tibial Plate - Modular - Size 3 - 80mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-43212026-06-26
09348215161378World Knee Cemented Titanium Tibial Plate - Modular - Size 4 - 80mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-44212026-06-26
09348215161385World Knee Cemented Titanium Tibial Plate - Modular - Size 5 - 80mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-45212026-06-26
09348215161392World Knee Cemented Titanium Tibial Plate - Modular - Size 6 - 80mmSIGNATURE ORTHOPAEDICS PTY LTD121-20-46212026-06-26