FDA.reportPublic FDA data

SIGMA

Primary DI
10603295502029
Brand
SIGMA
Company
DEPUY (IRELAND)
Model
1024-56-609
Catalog number
102456609
Device description
SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 6 RM/LL 9MM
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
10603295502029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329550202910603295502029

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
10603295033141S-ROM1365-16-5001365165002015-09-24
10603295033158S-ROM1365-17-5001365175002015-09-24
10603295033165S-ROM1365-18-5001365185002015-09-24
10603295033738S-ROM1365-41-5001365415002015-09-24
10603295033752S-ROM1365-42-5001365425002015-09-24
10603295033776S-ROM1365-43-5001365435002015-09-24
10603295033790S-ROM1365-44-5001365445002015-09-24
10603295033851S-ROM1365-45-5001365455002015-09-24
10603295033875S-ROM1365-47-5001365475002015-09-24
10603295034056S-ROM1365-61-5001365615002015-09-24
10603295034094S-ROM1365-62-5001365625002015-09-24
10603295034131S-ROM1365-63-5001365635002015-09-24
10603295034179S-ROM1365-64-5001365645002015-09-24
10603295034216S-ROM1365-65-5001365655002015-09-24
10603295034230S-ROM1365-66-5001365665002015-09-24
10603295170778S-ROM52-20225220222015-09-24
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00843575106476MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106483MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106490MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106506MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106513MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106520MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106537MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106544MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106551MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106568MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106575MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106582MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106599MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107619MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107626MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107633MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107640MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107657MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107664MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107671MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107688MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107695MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107701MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107718MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107725MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107732MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107749MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29