FDA.reportPublic FDA data

NA

Primary DI
04048844111250
Brand
NA
Company
implantcast GmbH
Model
25864000
Device description
ic head taper 12 / 14 mm BIOLOX® delta
Published
2026-05-06
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
OQIHip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048844111250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844111250040488441112504048844111250

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

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
324369826
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048844017309NA258628052026-06-02
04048844708443EPORE® XO022080502026-06-02
04048844711597EPORE® XO022080622026-06-02
04048844711726EPORE® XO02208058002026-06-02
04048844711740EPORE® XO02208062002026-06-02
04048844711795EPORE® XO02208072002026-06-02
04048844711870EPORE® XO022090562026-06-02
04048844711917EPORE® XO02209048002026-06-02
04048844711955EPORE® XO02209056002026-06-02
04048844711979EPORE® XO022090602026-06-02
04048844712020EPORE® XO02209064002026-06-02
04048844712068EPORE® XO02209068002026-06-02
04048844712099EPORE® XO022090722026-06-02
04048844712723NA025632462026-06-02
04048844712747NA025636542026-06-02
04048844712761NA025636622026-06-02
04048844712785NA025640542026-06-02
04048844712808NA025640622026-06-02
04048844712822NA025828422026-06-02
04048844712846NA025836502026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899177United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899184United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899191United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899207United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899214United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899221United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899238United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899245United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899252United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886910896United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886913361Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886913378Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886913385Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886913392Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886913408Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15