FDA.reportPublic FDA data

SIGMA

Primary DI
10603295501640
Brand
SIGMA
Company
DEPUY (IRELAND)
Model
1024-55-511
Catalog number
102455511
Device description
SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 5 LM/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
10603295501640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329550164010603295501640

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
10603295541325ATTUNE1518-20-1051518201052021-08-27
10603295541332ATTUNE1518-20-1061518201062021-08-27
10603295541349ATTUNE1518-20-1071518201072021-08-27
10603295541356ATTUNE1518-20-1081518201082021-08-27
10603295541363ATTUNE1518-20-1101518201102021-08-27
10603295541370ATTUNE1518-20-1121518201122021-08-27
10603295541387ATTUNE1518-20-1141518201142021-08-27
10603295541394ATTUNE1518-20-1161518201162021-08-27
10603295541400ATTUNE1518-20-2051518202052021-08-27
10603295541417ATTUNE1518-20-2061518202062021-08-27
10603295541424ATTUNE1518-20-2071518202072021-08-27
10603295541431ATTUNE1518-20-2081518202082021-08-27
10603295541448ATTUNE1518-20-2101518202102021-08-27
10603295541455ATTUNE1518-20-2121518202122021-08-27
10603295541462ATTUNE1518-20-2141518202142021-08-27
10603295541479ATTUNE1518-20-2161518202162021-08-27
10603295541486ATTUNE1518-20-3051518203052021-08-27
10603295541493ATTUNE1518-20-3061518203062021-08-27
10603295541509ATTUNE1518-20-3071518203072021-08-27
10603295541516ATTUNE1518-20-3081518203082021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247712Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247729Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247736Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247743Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247767Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247774Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247781Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247798Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247897Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247903Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247910Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247927Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247934Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247996Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248009Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248016Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248023Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248030Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248092Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248108Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248115Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248122Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248139Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248191Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248207Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248214Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248221Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248238Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248290Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248306Unity Total Knee SystemCORIN LTDOIY2026-10-19