FDA.reportPublic FDA data

ASPHERE

Primary DI
10603295033943
Brand
ASPHERE
Company
DEPUY (IRELAND)
Model
1365-52-100
Catalog number
136552100
Device description
ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +5 OFFSET
Published
2015-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
KWAProsthesis, hip, semi-constrained (metal uncemented acetabular component)
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)Orthopedic3
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082585000DEPUY ASPHERE M-SPEC HEADDePuy Orthopaedics, Inc.2008-12-04KWA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295033943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329503394310603295033943

GMDN Terms#

Term, Definition table
TermDefinition
Metallic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

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
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812142InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812180InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812197InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812203InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812210InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812227InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812234InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812241InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812258InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812265InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812272InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812289InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812296InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812319InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812326InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812333InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01