FDA.reportPublic FDA data

SIGMA

Primary DI
10603295002383
Brand
SIGMA
Company
DEPUY (IRELAND)
Model
1024-52-200
Catalog number
102452200
Device description
SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL TRAY UNICONDYLAR METAL BACKED SIZE 2 RM/LL
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
10603295002383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329500238310603295002383

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated unicondylar knee tibia prosthesis, metallicA sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component and an insert, and its implantation is intended to be performed with bone cement.

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