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
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24
10603295080145NA2001-80-5012001805012018-09-24
10603295080770NA2002-25-0002002250002018-09-24
10603295080787NA2002-27-0002002270002018-09-24
10603295080794NA2002-31-0002002310002018-09-24
10603295082057TRI-LOCK2012-03-0052012030052018-09-24
10603295082064TRI-LOCK2012-03-0102012030102018-09-24
10603295082071TRI-LOCK2012-03-0202012030202018-09-24
10603295082088TRI-LOCK2012-03-0302012030302018-09-24
10603295082095TRI-LOCK2012-03-0402012030402018-09-24
10603295082101TRI-LOCK2012-03-0502012030502018-09-24
10603295082118TRI-LOCK2012-03-0602012030602018-09-24
10603295082125TRI-LOCK2012-03-0702012030702018-09-24
10603295082132TRI-LOCK2012-03-0802012030802018-09-24
10603295082149TRI-LOCK2012-03-0902012030902018-09-24
10603295082156TRI-LOCK2012-03-1002012031002018-09-24
10603295082163TRI-LOCK2012-03-1102012031102018-09-24

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