FDA.reportPublic FDA data

SIGMA

Primary DI
10603295501596
Brand
SIGMA
Company
DEPUY (IRELAND)
Model
1024-55-411
Catalog number
102455411
Device description
SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 4LM/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
10603295501596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329550159610603295501596

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
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
10603295170679S-ROM52-15055215052015-09-24
10603295170686S-ROM52-15255215252015-09-24
10603295170693S-ROM52-15305215302015-09-24
10603295170709S-ROM52-15355215352015-09-24
10603295170716S-ROM52-15405215402015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00193982533700ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533717ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533724ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533731ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533748ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533861ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533878ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533885ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533892ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533908ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533915ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533922ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533939ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533946ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982677428ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982677435ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982677442ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982677459ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00843575106445MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106452MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106469MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29