FDA.reportPublic FDA data

JOURNEY

Primary DI
03596010671998
Brand
JOURNEY
Company
Smith & Nephew, Inc.
Model
74031214
Catalog number
74031214
Device description
JOURNEY II TKA FEMORAL TRIAL RIGHT SIZE 4
Published
2015-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121443000JOURNEY II CR KNEE SYSTEMSmith & Nephew, Inc.2012-08-13JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010671998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010671998035960106719983596010671998

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur prosthesis trialA copy of a final femur prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes femoral articulation trials, femoral spacer trials, femoral wedge/augment trials, anterior stop trials, stem adaptor trials, and stem trials. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556923023NASmith & Nephew, Inc.JWH2026-07-16
08800017262819EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262826EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262833EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262840EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262857EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262864EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262871EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262888EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262895EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262901EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262918EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262925EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262932EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262949EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262956EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262963EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262970EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262987EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262994EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263007EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263014EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263021EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263038EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263045EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263052EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263069EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263076EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263083EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263090EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10