FDA.reportPublic FDA data

PINNACLE

Primary DI
10603295012276
Brand
PINNACLE
Company
DEPUY ORTHOPAEDICS, INC.
Model
1218-44-672
Catalog number
121844672
Device description
PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 NEUTRAL 44mm ID 72mm OD
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
10603295012276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329501227610603295012276

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295562108VELYS Hip Navigation4515801514515801512026-03-24
10603295553625ATTUNE2999-67-0322999670322026-02-17
10603295553632ATTUNE2999-67-0332999670332026-02-17
10603295553649ATTUNE2999-67-0342999670342026-02-17
10603295553656ATTUNE2999-67-0352999670352026-02-17
10603295554974EMPHASYS2999-67-0462999670462026-02-04
10603295080121AML EXCEL2001-65-0002001650002018-06-15
10603295082408DURALOC2015-24-0002015240002018-09-24
10603295083382SIGMA2024-57-1112024571112018-09-24
10603295084075SIGMA2024-85-0052024850052018-09-24
10603295088042GLOBAL FX2128-01-0222128010222018-09-24
10603295090540GLOBAL AP2130-01-0552130010552018-09-24
10603295090687GLOBAL AP2130-04-0002130040002018-09-24
10603295094005NA2178-30-1222178301222018-09-24
10603295095651LCS COMPLETION2178-60-0282178600282018-09-24
10603295096184NA2178-63-1242178631242018-09-24
10603295096191NA2178-63-1262178631262018-09-24
10603295098935PINNACLE2217-50-0042217500042018-09-24
10603295098942PINNACLE2217-50-0052217500052018-09-24
10603295098959PINNACLE2217-50-0062217500062018-09-24

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