FDA.reportPublic FDA data

SIGMA

Primary DI
10603295002413
Brand
SIGMA
Company
DEPUY (IRELAND)
Model
1024-52-500
Catalog number
102452500
Device description
SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL TRAY UNICONDYLAR METAL BACKED SIZE 5 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
10603295002413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329500241310603295002413

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
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
07613327049305AvonHowmedica Osteonics Corp.NPJ2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
00848486016401MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016401MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016418MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016418MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016432MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016432MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016449MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016449MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016456MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016456MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016463MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016463MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016487MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016487MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016494MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016494MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016500MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016500MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016517MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016517MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016531MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016531MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016548MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016548MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016555MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016555MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016562MakoMAKO SURGICAL CORP.NPJ2015-11-04