FDA.reportPublic FDA data

JOURNEY

Primary DI
03596010544223
Brand
JOURNEY
Company
Smith & Nephew, Inc.
Model
71461015
Catalog number
71461015
Device description
JOURNEY PFJ IMPLANT MEDIUM RIGHT
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051086000
K093056000
K230653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051086000SMITH & NEPHEW PATELLO-FEMORAL IMPLANTSmith & Nephew, Inc.2005-05-31KRR
K093056000SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEMSmith & Nephew, Inc.2009-12-15NPJ
K230653000Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial BaseplatesSmith & Nephew, Inc.2023-05-04JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010544223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010544223035960105442233596010544223

GMDN Terms#

Term, Definition table
TermDefinition
Patellofemoral joint prosthesisA sterile implantable device designed to replace the patellofemoral articulating surface of the knee to treat isolated patellofemoral disease, typically osteoarthritis. The device is made of metal (e.g., oxidized zirconium alloy) and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; it may include fixation devices (e.g., pegs) for implantation which is intended to be performed with bone cement.

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544230JOURNEY71461016714610162015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
07613327049305AvonHowmedica Osteonics Corp.KRR2017-06-19
07613327049305AvonHowmedica Osteonics Corp.HSX2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327014549ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014587ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014594ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014600ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.HSX2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015508TriathlonHowmedica Osteonics Corp.HSX2015-09-24
07613327015515TriathlonHowmedica Osteonics Corp.HSX2015-09-24
07613327015515TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015522TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015522TriathlonHowmedica Osteonics Corp.HSX2015-09-24
07613327015539TriathlonHowmedica Osteonics Corp.HSX2015-09-24
07613327015546TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015546TriathlonHowmedica Osteonics Corp.HSX2015-09-24
07613327015553TriathlonHowmedica Osteonics Corp.HSX2015-09-24
07613327015553TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015560TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015577TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015584TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015591TriathlonHowmedica Osteonics Corp.HSX2015-09-24
07613327015591TriathlonHowmedica Osteonics Corp.KRR2015-09-24