FDA.reportPublic FDA data

Corin Metafix Hip Stem

Primary DI
05055196900882
Brand
Corin Metafix Hip Stem
Company
CORIN LTD
Model
579.2009
Catalog number
579.2009
Device description
Metafix Size 9 Standard (125º)
Published
2016-08-17
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
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082525000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082525000CORIN METAFIX FEMORAL STEMCorin USA2010-02-04LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055196900882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055196900882050551969008825055196900882

GMDN Terms#

Term, Definition table
TermDefinition
Coated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+441285659866rachel.king@coringroup.com
+441285659866lucinda.gerber@coringroup.com

Regulatory Flags#

DUNS number
295437313
Device count
1
DM exempt
true
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
05056139247712Unity Total Knee System11261092026-10-19
05056139247729Unity Total Knee System11262092026-10-19
05056139247736Unity Total Knee System112640911264092026-10-19
05056139247743Unity Total Knee System112630911263092026-10-19
05056139247767Unity Total Knee System112680911268092026-10-19
05056139247774Unity Total Knee System112670911267092026-10-19
05056139247781Unity Total Knee System112660911266092026-10-19
05056139247798Unity Total Knee System112650911265092026-10-19
05056139247897Unity Total Knee System11262102026-10-19
05056139247903Unity Total Knee System11262112026-10-19
05056139247910Unity Total Knee System11262122026-10-19
05056139247927Unity Total Knee System112621411262142026-10-19
05056139247934Unity Total Knee System112621611262162026-10-19
05056139247996Unity Total Knee System112631011263102026-10-19
05056139248009Unity Total Knee System112631111263112026-10-19
05056139248016Unity Total Knee System112631211263122026-10-19
05056139248023Unity Total Knee System112631411263142026-10-19
05056139248030Unity Total Knee System112631611263162026-10-19
05056139248092Unity Total Knee System112641011264102026-10-19
05056139248108Unity Total Knee System112641111264112026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899177United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899184United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899191United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899207United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899214United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899221United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899238United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899245United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899252United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886910896United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886913361Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886913378Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886913385Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886913392Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886913408Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15