FDA.reportPublic FDA data

SIGMA

Primary DI
10603295501541
Brand
SIGMA
Company
DEPUY (IRELAND)
Model
1024-55-311
Catalog number
102455311
Device description
SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 3LM/RL 11MM
Published
2021-04-23
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
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193549000SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC2020-04-16HRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295501541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329550154110603295501541

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee insertA sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295005438GLOBAL AP1130-02-0001130020002015-09-24
10603295218289S-ROM87-34358734352015-09-24
10603295218470S-ROM87-35568735562015-09-24
10603295218487S-ROM87-35578735572015-09-24
10603295218951S-ROM87-59878759872015-09-24
10603295519935VELYS4515-70-2264515702262021-05-26
10603295519430VELYS4515-70-1024515701022021-05-13
10603295519492VELYS4515-70-1014515701012021-05-13
10603295519515VELYS4515-70-1004515701002021-05-13
10603295519379VELYS4515-70-1074515701072021-05-07
10603295519461VELYS4515-70-1054515701052021-05-07
10603295519478VELYS4515-70-1064515701062021-05-07
10603295519485VELYS4515-70-1094515701092021-05-07
10603295170655S-ROM52-15035215032015-09-24
10603295170662S-ROM52-15045215042015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536705Identity CR KARestor3d, Inc.OIY2026-09-25
00840097536712Identity CR KARestor3d, Inc.OIY2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536781Identity CR KARestor3d, Inc.OIY2026-09-25
00840097536798Identity CR KARestor3d, Inc.OIY2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
E31442411410SignatureMaterialise NVOIY2026-09-24
E31442411410SignatureMaterialise NVHRY2026-09-24
E31442422415SignatureMaterialise NVOIY2026-09-24
E31442422450SignatureMaterialise NVOIY2026-09-24
E31442422451SignatureMaterialise NVOIY2026-09-24
E31442422452SignatureMaterialise NVOIY2026-09-24
E31442422453SignatureMaterialise NVOIY2026-09-24
E31442422455SignatureMaterialise NVOIY2026-09-24
E31442422456SignatureMaterialise NVOIY2026-09-24
E31442422457SignatureMaterialise NVOIY2026-09-24
E31442422458SignatureMaterialise NVOIY2026-09-24
E31442422460SignatureMaterialise NVOIY2026-09-24
E31442422461SignatureMaterialise NVOIY2026-09-24
E31442422462SignatureMaterialise NVOIY2026-09-24
E31442422463SignatureMaterialise NVOIY2026-09-24
E31442422465SignatureMaterialise NVOIY2026-09-24
E31442422466SignatureMaterialise NVOIY2026-09-24
E31442422467SignatureMaterialise NVOIY2026-09-24