FDA.reportPublic FDA data

OXINIUM

Primary DI
03596010483799
Brand
OXINIUM
Company
Smith & Nephew, Inc.
Model
71245036
Catalog number
71245036
Device description
OXINIUM UNI FEMORAL IMPLANT MAGNUM +
Published
2015-08-29
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022958000
K230653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022958000TOTAL HIP FEMORAL HEADS AND LINERSSmith & Nephew, Inc.2002-10-02JDI
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
03596010483799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010483799035960104837993596010483799

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee prosthesisA sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30
00885556925188REAL INTELLIGENCEROB100022FROB100022F2026-07-30
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
20885556628908NavioPFSDV0016PFSDV00162016-09-21
00885556820964General InstrumentsMA3511NDMA3511ND2023-10-27
00885556822722Capture High Torque Screw SystemMAT-000-02MAT-000-022022-12-21
00885556822937Total Foot System 23210103210102022-12-21
00885556822944Total Foot System 23210123210122022-12-21
00885556828090XT Revision Ankle Replacement SystemMJV551TMJV551T2022-12-21
00885556832431Salto Talaris Total Ankle ProsthesisMJU012TMJU012T2022-12-21
00885556837825Total Foot System 23820003820002022-12-22
00885556840375Total Wrist Fusion System3035113035112022-12-21
00885556841525XT Revision Ankle Replacement SystemMJU944TMJU944T2022-12-21
00885556855003Freedom Wrist Arthroplasty System3480593480592022-12-22
00885556858301PyroCarbon PIP Total Joint SystemOSG-200-00OSG-200-002022-12-22
00885556858325PyroCarbon PIP Total Joint SystemOSG-200-10PVOSG-200-10PV2022-12-22
00885556858349PyroCarbon PIP Total Joint SystemOSG-200-20PVOSG-200-20PV2022-12-22
00885556858363PyroCarbon PIP Total Joint SystemOSG-200-30PVOSG-200-30PV2022-12-22
00885556858387PyroCarbon PIP Total Joint SystemOSG-200-40PVOSG-200-40PV2022-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629032071LineageMicroport Orthopedics Inc.JDI2026-08-18
00192629031937LineageMicroport Orthopedics Inc.JDI2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14