FDA.reportPublic FDA data

SIGMA

Primary DI
10603295002857
Brand
SIGMA
Company
DEPUY (IRELAND)
Model
1024-54-309
Catalog number
102454309
Device description
SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 3 RM/LL 9mm XLK
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
NPJPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070267000
K233980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070267000DEPUY GCK TIBIAL COMPONENTSDePuy Orthopaedics, Inc.2007-08-17HRY
K233980000ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemDepuy Ireland UC2024-03-21KRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295002857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329500285710603295002857

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
07613327127423INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127447INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127447INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127461INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127461INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127478INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127478INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127485INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127485INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327049305AvonHowmedica Osteonics Corp.NPJ2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24