FDA.reportPublic FDA data

GMK 3D Metal Tibial Tray

Primary DI
07630345710796
Brand
GMK 3D Metal Tibial Tray
Company
Medacta International SA
Model
02.12.3D02L
Device description
3DMetal Tibial Tray Size 2L
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
07630345710796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345710796076303457107967630345710796

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
07630345716743SportsMed Instruments05.05.10.01452026-08-17
07630345716750SportsMed Instruments05.05.10.01462026-08-17
07630971256293Accessories Arthroscopic05.13.10.01402026-07-28
07630345700551NextAR TSA Platform5.3KSWNXAR2026-07-10
07630542776755Surgical Manual Instrument01.10.10.20922026-07-07
07630542778285Surgical Manual Instrument01.10.10.20932026-07-07
07630542778292Surgical Manual Instrument01.10.10.20942026-07-07
07630542791659Surgical Manual Instrument03.51.10.07412026-07-07
07630542788314AMIStem-P13.000092026-06-08
07630542788321AMIStem-P13.000102026-06-08
07630542788338AMIStem-P13.000112026-06-08
07630542788345AMIStem-P13.000122026-06-08
07630542788352AMIStem-P13.000132026-06-08
07630542788369AMIStem-P13.000142026-06-08
07630542788376AMIStem-P13.000152026-06-08
07630971243637AMIStem-P Short Neck01.18.4592020-01-29
07630971243644AMIStem-P Short Neck01.18.4602020-01-29
07630971243651AMIStem-P Short Neck01.18.4612020-01-29
07630971243668AMIStem-P Short Neck01.18.4622020-01-29
07630971243675AMIStem-P Short Neck01.18.4632020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982533663ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533663ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533670ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533670ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533687ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533687ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533694ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533694ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533700ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533700ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533717ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533717ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533724ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533724ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533731ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533731ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533748ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533748ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533861ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533861ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533878ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533878ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533885ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533885ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533892ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533892ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533908ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533908ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533915ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533915ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14