FDA.reportPublic FDA data

Consensus Knee System

Primary DI
00840286814881
Brand
Consensus Knee System
Company
Shalby Advanced Technologies, Inc.
Model
2141-1-3414
Catalog number
2141-1-3414
Device description
Tibial Insert, PCL Substituting, L, 3-4, 14mm
Published
2022-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286814881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286814881008402868148818402868148810840286814881

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(916)355-7100khansen@consensusortho.com

Regulatory Flags#

DUNS number
085976260
Device count
1
DM exempt
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840286860147Tahoe Unicompartmental Knee System3000-0-17013000-0-17012026-07-10
00840286860154Tahoe Unicompartmental Knee System3000-0-17023000-0-17022026-07-10
00840286860161Tahoe Unicompartmental Knee System3000-0-17033000-0-17032026-07-10
00840286860178Tahoe Unicompartmental Knee System3000-0-17043000-0-17042026-07-10
00840286860185Tahoe Unicompartmental Knee System3000-0-17053000-0-17052026-07-10
00840286860192Tahoe Unicompartmental Knee System3000-0-17063000-0-17062026-07-10
00840286860208Tahoe Unicompartmental Knee System3000-0-17073000-0-17072026-07-10
00840286860215Tahoe Unicompartmental Knee System3000-0-17083000-0-17082026-07-10
00840286860239Tahoe Unicompartmental Knee System3000-0-16023000-0-16022026-07-10
00840286860246Tahoe Unicompartmental Knee System3000-0-16033000-0-16032026-07-10
00840286860253Tahoe Unicompartmental Knee System3000-0-16043000-0-16042026-07-10
00840286860260Tahoe Unicompartmental Knee System3000-0-16053000-0-16052026-07-10
00840286860277Tahoe Unicompartmental Knee System3000-0-16063000-0-16062026-07-10
00840286860284Tahoe Unicompartmental Knee System3000-0-16073000-0-16072026-07-10
00840286860291Tahoe Unicompartmental Knee System3000-0-16083000-0-16082026-07-10
00840286860307Tahoe Unicompartmental Knee System3600-0-00003600-0-00002026-07-10
00840286860314Tahoe Unicompartmental Knee System3600-0-00013600-0-00012026-07-10
00840286860321Tahoe Unicompartmental Knee System3600-0-00023600-0-00022026-07-10
00840286860338Tahoe Unicompartmental Knee System3600-0-00033600-0-00032026-07-10
00840286860345Tahoe Unicompartmental Knee System3600-0-00043600-0-00042026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536705Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536712Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536781Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536798Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
E31442411410SignatureMaterialise NVJWH2026-09-24
E31442422415SignatureMaterialise NVJWH2026-09-24
E31442422450SignatureMaterialise NVJWH2026-09-24
E31442422451SignatureMaterialise NVJWH2026-09-24
E31442422452SignatureMaterialise NVJWH2026-09-24
E31442422453SignatureMaterialise NVJWH2026-09-24
E31442422455SignatureMaterialise NVJWH2026-09-24
E31442422456SignatureMaterialise NVJWH2026-09-24
E31442422457SignatureMaterialise NVJWH2026-09-24
E31442422458SignatureMaterialise NVJWH2026-09-24
E31442422460SignatureMaterialise NVJWH2026-09-24
E31442422461SignatureMaterialise NVJWH2026-09-24
E31442422462SignatureMaterialise NVJWH2026-09-24
E31442422463SignatureMaterialise NVJWH2026-09-24
E31442422465SignatureMaterialise NVJWH2026-09-24
E31442422466SignatureMaterialise NVJWH2026-09-24
E31442422467SignatureMaterialise NVJWH2026-09-24
E31442422468SignatureMaterialise NVJWH2026-09-24