FDA.reportPublic FDA data

Metafix Hip Stem

Primary DI
05055343894033
Brand
Metafix Hip Stem
Company
CORIN LTD
Model
340.474
Device description
125˚ Short Neck Trial
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
KWLProsthesis, Hip, Hemi-, Femoral, Metal
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153381000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153381000Corin Metafix Hip StemCorin U.S.A. Limited2016-01-21LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055343894033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055343894033050553438940335055343894033

GMDN Terms#

Term, Definition table
TermDefinition
Femoral stem prosthesis trialA copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
295437313
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056139247750Unity Total Knee System112690911269092026-10-23
05056139247804Unity Total Knee System112710911271092026-10-23
05056139247811Unity Total Knee System112720911272092026-10-23
05056139247828Unity Total Knee System112730911273092026-10-23
05056139247835Unity Total Knee System112740911274092026-10-23
05056139247941Unity Total Knee System112721011272102026-10-23
05056139247958Unity Total Knee System112721111272112026-10-23
05056139247965Unity Total Knee System112721211272122026-10-23
05056139247972Unity Total Knee System112721411272142026-10-23
05056139247989Unity Total Knee System112721611272162026-10-23
05056139248047Unity Total Knee System112731011273102026-10-23
05056139248054Unity Total Knee System112731111273112026-10-23
05056139248061Unity Total Knee System112731211273122026-10-23
05056139248078Unity Total Knee System112731411273142026-10-23
05056139248085Unity Total Knee System112731611273162026-10-23
05056139248146Unity Total Knee System112741011274102026-10-23
05056139248153Unity Total Knee System112741111274112026-10-23
05056139248160Unity Total Knee System112741211274122026-10-23
05056139248177Unity Total Knee System112741411274142026-10-23
05056139248184Unity Total Knee System112741611274162026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260056885860InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885860InterSpace® Hip Mold Short StemOSARTIS GmbHKWY2026-10-29
04260056885884InterSpace® Hip Mold Short StemOSARTIS GmbHKWY2026-10-29
04260056885884InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885907InterSpace® Hip Mold Short StemOSARTIS GmbHKWY2026-10-29
04260056885907InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885921InterSpace® Hip Mold Long StemOSARTIS GmbHKWY2026-10-29
04260056885921InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885945InterSpace® Hip Mold Long StemOSARTIS GmbHKWY2026-10-29
04260056885945InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885969InterSpace® Hip Mold Long StemOSARTIS GmbHKWY2026-10-29
04260056885969InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885983InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056885983InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886003InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886003InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056886027InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056886027InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886041InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056886041InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886065InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056886065InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15