FDA.reportPublic FDA data

GMK 3D Metal Tibial Tray

Primary DI
07630345710857
Brand
GMK 3D Metal Tibial Tray
Company
Medacta International SA
Model
02.12.3D05L
Device description
3DMetal Tibial Tray Size 5L
Published
2022-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221850000
K253328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221850000GMK 3D Metal Tibial TrayMedacta International S.A.2022-08-23MBH
K253328000GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.2026-02-26MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630345710857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345710857076303457108577630345710857

GMDN Terms#

Term, Definition table
TermDefinition
Trabeculated bicondylar knee tibia prosthesisAn 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., tantalum alloy) and has a convoluted/perforated surface 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 without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630345700551NextAR TSA Platform5.3KSWNXAR2026-07-10
07630345729316NextAR TSA Platform5.3SSWNXAR2026-04-13
07630345728975Navigation System for Knee surgery33.22.10002026-01-26
07630699701792Navigation System for Knee surgery33.22.1000US2026-01-26
07630345725912NextAR Spine Platform98.46.NEXTAR2026-01-20
07630542722332NextAR Hip Platform09.23.10.IMU2026-01-14
07630542779626NextAR Hip Platform5.3HSWNXAR2026-01-14
07630542759130NextAR™ Spine03.57.10.02622025-11-14
07630542759147NextAR™ Spine03.57.10.02632025-11-14
07630542720390NextAR Spine Platform03.57.10.02032025-09-19
07630542720406NextAR Spine Platform03.57.10.02042025-09-19
07630542720413NextAR Spine Platform03.57.10.02052025-09-19
07630542720420NextAR Spine Platform03.57.10.02062025-09-19
07630542720437NextAR Spine Platform03.57.10.02072025-09-19
07630542720444NextAR Spine Platform03.57.10.02082025-09-19
07630542720451NextAR Spine Platform03.57.10.02092025-09-19
07630542765346NextAR (TM) Shoulder Platform04.01.10.09022025-09-17
07630542765353NextAR (TM) Shoulder Platform04.01.10.09032025-09-17
07630542765360NextAR (TM) Shoulder Platform04.01.10.09042025-09-17
07630542765421NextAR (TM) Shoulder Platform04.01.10.09102025-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629298675ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298675ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298682ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298682ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298699ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298699ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298705ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298705ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298712ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298712ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298729ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298729ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298736ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298736ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298743ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298743ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298750ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298750ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298767ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298767ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298774ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298774ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298781ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298781ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298798ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298798ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298804ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298804ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298811ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298811ProphecyMicroport Orthopedics Inc.MBH2020-09-25