FDA.reportPublic FDA data

PINNACLE

Primary DI
10603295012290
Brand
PINNACLE
Company
DEPUY ORTHOPAEDICS, INC.
Model
1218-44-676
Catalog number
121844676
Device description
PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 NEUTRAL 44mm ID 76mm OD
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
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295012290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329501229010603295012290

GMDN Terms#

Term, Definition table
TermDefinition
Constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene) and may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
080506581
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295015154DURALOC1220-28-1481220281482015-09-24
10603295015161DURALOC1220-28-1501220281502015-09-24
10603295015178DURALOC1220-28-1521220281522015-09-24
10603295015185DURALOC1220-28-1541220281542015-09-24
10603295015192DURALOC1220-28-1561220281562015-09-24
10603295015208DURALOC1220-28-1581220281582015-09-24
10603295015215DURALOC1220-28-1601220281602015-09-24
10603295015222DURALOC1220-28-1621220281622015-09-24
10603295015239DURALOC1220-28-1641220281642015-09-24
10603295015246DURALOC1220-28-1661220281662015-09-24
10603295015536DURALOC1220-32-1521220321522015-09-24
10603295015543DURALOC1220-32-1541220321542015-09-24
10603295015550DURALOC1220-32-1561220321562015-09-24
10603295015567DURALOC1220-32-1581220321582015-09-24
10603295015574DURALOC1220-32-1601220321602015-09-24
10603295015581DURALOC1220-32-1621220321622015-09-24
10603295015598DURALOC1220-32-1641220321642015-09-24
10603295015604DURALOC1220-32-1661220321662015-09-24
10603295155010NA2841-10-0002841100002018-09-24
10603295552390ATTUNE2999-66-9712999669712026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862661456N/AExactech, Inc.KWZ2026-03-19
10885862661463N/AExactech, Inc.KWZ2026-03-19
10885862661470N/AExactech, Inc.KWZ2026-03-19
10885862661487NovationExactech, Inc.KWZ2026-03-19
10885862661494NovationExactech, Inc.KWZ2026-03-19
10885862661500NovationExactech, Inc.KWZ2026-03-19
10885862661517NovationExactech, Inc.KWZ2026-03-19
10885862661524NovationExactech, Inc.KWZ2026-03-19
00889024683938G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024683945G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024686649G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024686656G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024686670G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024686694G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024686700G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024686731G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
07630542722653Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722660Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722677Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722684Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722691Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722707Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722714Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722721Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722738Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722745Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722752Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722769Mpact Constrained LinerMedacta International SAKWZ2025-08-06
00889024670099Trabecular Metal® Acetabular Revision SystemZimmer, Inc.KWZ2024-11-05
00889024670105Trabecular Metal® Acetabular Revision SystemZimmer, Inc.KWZ2024-11-05