FDA.reportPublic FDA data

Femoral Head

Primary DI
08033390298162
Brand
Femoral Head
Company
LIMACORPORATE SPA
Model
5010.42.361
Catalog number
5010.42.361
Device description
Femoral Head - Dia.36mm Short Taper 12/14
Published
2025-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141327000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141327000MINIMA S SYSTEMLima Corporate S.P.A.2014-08-06LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033390298162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390298162080333902981628033390298162

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). 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 with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
432066322
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033390201858Smart SPACE SHOULDER0023.L1.N330023.L1.N332023-02-18
08033390201872Smart SPACE SHOULDER0023.L2.N330023.L2.N332023-02-18
08033390201896Smart SPACE SHOULDER0023.L3.N330023.L3.N332023-02-18
08033390201919Smart SPACE SHOULDER0023.R1.N330023.R1.N332023-02-18
08033390201933Smart SPACE SHOULDER0023.R2.N330023.R2.N332023-02-18
08033390201957Smart SPACE SHOULDER0023.R3.N330023.R3.N332023-02-18
08033390239509Smart SPACE SHOULDER0023.R4.N330023.R4.N332023-02-18
08033390239516Smart SPACE SHOULDER0023.L4.N330023.L4.N332023-02-18
08033390216036SMR Shoulder1379.5G.0301379.5G.0302026-05-11
08033390216043SMR Shoulder1379.5G.1201379.5G.1202026-05-11
08033390216050SMR Shoulder1379.5G.1241379.5G.1242026-05-11
08033390216067SMR Shoulder1379.5G.3201379.5G.3202026-05-11
08033390216074SMR Shoulder1379.5G.3221379.5G.3222026-05-11
08033390216081SMR Shoulder1379.5G.3241379.5G.3242026-05-11
08033390216098SMR Shoulder1379.5G.3301379.5G.3302026-05-11
08033390272797SMR System1375.15.6051375.15.6052026-02-25
08033390272803SMR System1375.15.6101375.15.6102026-02-25
08033390272810SMR System1375.15.6201375.15.6202026-02-25
08033390002233SMR System1362.09.0101362.09.0102026-02-19
08033390002240SMR System1362.09.0151362.09.0152026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247293Icona Hip StemCORIN LTDKWY2025-04-07
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
10885862015181AuraExactech, Inc.JDI2022-10-04
10885862015198AuraExactech, Inc.JDI2022-10-04
10885862015204AuraExactech, Inc.JDI2022-10-04
10885862015211AuraExactech, Inc.JDI2022-10-04
10885862013743NAExactech, Inc.JDI2022-09-20
10885862013743NAExactech, Inc.LPH2022-09-20
10885862013750NAExactech, Inc.JDI2022-09-20
10885862013750NAExactech, Inc.LPH2022-09-20
10885862010551NAExactech, Inc.LPH2022-08-18
10885862010551NAExactech, Inc.JDI2022-08-18
10885862010575NAExactech, Inc.JDI2022-08-18
10885862010575NAExactech, Inc.LPH2022-08-18
10885862010582NAExactech, Inc.JDI2022-08-18
10885862010582NAExactech, Inc.LPH2022-08-18
10885862010872NAExactech, Inc.JDI2022-08-18
10885862010872NAExactech, Inc.LPH2022-08-18
10885862010872NAExactech, Inc.LZO2022-08-18
10885862010889NAExactech, Inc.LZO2022-08-18
10885862010889NAExactech, Inc.LPH2022-08-18
10885862010889NAExactech, Inc.JDI2022-08-18
10885862010896NAExactech, Inc.JDI2022-08-18
10885862010896NAExactech, Inc.LZO2022-08-18
10885862010896NAExactech, Inc.LPH2022-08-18
10885862015112AuraExactech, Inc.JDI2022-08-18
10885862015129AuraExactech, Inc.JDI2022-08-18
10885862015136AuraExactech, Inc.JDI2022-08-18
10885862015143AuraExactech, Inc.JDI2022-08-18
10885862015150AuraExactech, Inc.JDI2022-08-18