FDA.reportPublic FDA data

Trinity Acetabular Hip System

Primary DI
05055343897522
Brand
Trinity Acetabular Hip System
Company
CORIN LTD
Model
9214542
Catalog number
9214542
Device description
Liner Trial (Size 4)
Published
2019-01-08
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
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170359000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170359000Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017-10-31LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055343897522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055343897522050553438975225055343897522

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. 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
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15