FDA.reportPublic FDA data

SIGMA

Primary DI
10603295001690
Brand
SIGMA
Company
DEPUY (IRELAND)
Model
1024-04-400
Catalog number
102404400
Device description
SIGMA HIGH PERFORMANCE PARTIAL KNEE PFJ TROCHLEA SIZE 4 RIGHT CEMENTED
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
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, 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
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061648000
K233980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061648000DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)DePuy Orthopaedics, Inc.2006-09-11NPJ
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
10603295001690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329500169010603295001690

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated unicondylar knee femur prosthesisA sterile implantable device designed to replace the bearing surface of one femoral condyle (femoral 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 by promoting bone ingrowth. The device articulates with a tibial 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
00888867106697Arthrex®ARTHREX, INC.KRR2017-02-15
07613154557431INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
00848486016401MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016401MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016401MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016418MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016418MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016418MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016432MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016432MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016432MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016449MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016449MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016449MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016456MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016456MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016456MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016463MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016463MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016463MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016487MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016487MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016487MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016494MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016494MakoMAKO SURGICAL CORP.NPJ2015-11-04
00848486016494MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016500MakoMAKO SURGICAL CORP.KRR2015-11-04
00848486016500MakoMAKO SURGICAL CORP.HRY2015-11-04