FDA.reportPublic FDA data

Revision Femoral Head

Primary DI
08033390296984
Brand
Revision Femoral Head
Company
LIMACORPORATE SPA
Model
5010.42.031
Catalog number
5010.42.031
Device description
Revision Femoral Head - Dia.32mm 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
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243809000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243809000Biolox® Delta Revision headsLimacorporate2025-03-04LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033390296984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390296984080333902969848033390296984

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
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
08033390002257SMR System1362.09.0201362.09.0202026-02-19
08033390050029SMR System1362.09.1151362.09.1152026-02-19
08033390050036SMR System1362.09.1201362.09.1202026-02-19
08033390191135PRIMA1367.09.3761367.09.3762026-02-19
08033390201971PRIMA1367.09.2001367.09.2002026-02-19
08033390202299PRIMA1367.09.2031367.09.2032026-02-19
08033390202305PRIMA1367.09.2061367.09.2062026-02-19
08033390202312PRIMA1367.09.2701367.09.2702026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536675Velora Acetabular System InstrumentationRestor3d, Inc.LPH2026-08-19
00192629031999LineageMicroport Orthopedics Inc.LPH2026-08-18
00192629032064LineageMicroport Orthopedics Inc.LZO2026-08-18
00192629080515MICROPORTMicroport Orthopedics Inc.LPH2026-08-18
00192629176553MICROPORTMicroport Orthopedics Inc.LPH2026-08-18
00192629031951MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629031968LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629031975LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629031982LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629032033LineageMicroport Orthopedics Inc.LZO2026-08-17
00192629032040LineageMicroport Orthopedics Inc.LZO2026-08-17
00192629032057LineageMicroport Orthopedics Inc.LZO2026-08-17
00192629163584MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176515MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176522MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176539MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176546MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14