FDA.reportPublic FDA data

JOURNEY

Primary DI
03596010573315
Brand
JOURNEY
Company
Smith & Nephew, Inc.
Model
71461011
Catalog number
71461011
Device description
JOURNEY PFJ IMPLANT EXTRA-SMALL 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
03596010573315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010573315035960105733153596010573315

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
00885556922170NA74034437740344372026-07-31
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30
00885556925188REAL INTELLIGENCEROB100022FROB100022F2026-07-30
00885556925195REAL INTELLIGENCEROB10024FROB10024F2026-07-30
00885556925201REAL INTELLIGENCEROB10025FROB10025F2026-07-30
00885556925218REAL INTELLIGENCEROB10027FROB10027F2026-07-30
00885556925225REAL INTELLIGENCEROB10003FROB10003F2026-07-30
00885556925232REAL INTELLIGENCEROB10013FROB10013F2026-07-30
00885556925249REAL INTELLIGENCEROB10015FROB10015F2026-07-30
00885556832448Salto Talaris Total Ankle ProsthesisMJU048TMJU048T2023-02-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
00822409130153N/AOrtho Development CorporationHSX2025-03-17
00822409130160N/AOrtho Development CorporationHSX2025-03-17
00822409130177N/AOrtho Development CorporationHSX2025-03-17
00822409130184N/AOrtho Development CorporationHSX2025-03-17
00822409130191N/AOrtho Development CorporationHSX2025-03-17
00822409130207N/AOrtho Development CorporationHSX2025-03-17
00822409130214N/AOrtho Development CorporationHSX2025-03-17
00822409130221N/AOrtho Development CorporationHSX2025-03-17
00822409130238N/AOrtho Development CorporationHSX2025-03-17
00822409130245N/AOrtho Development CorporationHSX2025-03-17
00822409130252N/AOrtho Development CorporationHSX2025-03-17
00822409130269N/AOrtho Development CorporationHSX2025-03-17
00888867106697Arthrex®ARTHREX, INC.KRR2017-02-15
00888867106697Arthrex®ARTHREX, INC.HSX2017-02-15
07613154557431INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
00848486016401MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016401MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016418MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016418MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016432MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016432MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016449MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016449MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016456MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016456MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016463MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016463MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016487MakoMAKO SURGICAL CORP.HSX2015-11-04