FDA.reportPublic FDA data

Trinity EVO

Primary DI
05056139248795
Brand
Trinity EVO
Company
CORIN LTD
Model
CO76.3243.000.00
Device description
Trinity™ EVO Cup Ø60mm Taper Size 5 Cap Coating
Published
2025-07-02
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
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, 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
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242744000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242744000Trinity EVO Acetabular ShellCorin U.S.A. Limited2025-06-05LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056139248795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056139248795050561392487955056139248795

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401285649231customersupport@coringroup.com

Regulatory Flags#

DUNS number
295437313
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056139245374Apollo KneeCOR.TS.13002025-04-07
05056139247293Icona Hip Stem72611112025-04-07
05056139250644Apollo KneeTKR.KT.13002025-04-07
05056139244933Apollo KneeTKR.BB.14022025-04-07
05056139244940Apollo KneeTKR.BB.14032025-04-07
05056139244971Apollo KneeTKR.IN.16002025-04-07
05056139244988Apollo KneeTKR.IN.17002025-04-07
05056139244995Apollo KneeTKR.BB.17002025-04-07
05056139245008Apollo KneeTKR.BB.17012025-04-07
05056139245015Apollo KneeTKR.BB.17022025-04-07
05056139245022Apollo KneeTKR.BB.17032025-04-07
05056139245039Apollo KneeTKR.BB.17042025-04-07
05056139245053Apollo KneeTKR.BB.17052025-04-07
05056139245060Apollo KneeTKR.BB.17062025-04-07
05056139245077Apollo KneeTKR.BB.17072025-04-07
05056139245145Apollo KneeTKR.IN.18002025-04-07
05056139245176Apollo KneeTKR.BB.15002025-04-07
05056139245718Apollo KneeTKR.IN.14002025-04-07
05056139245770Apollo KneeTKR.BB.11002025-04-07
05056139245787Apollo KneeTKR.BB.11012025-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
10885862013743NAExactech, Inc.LPH2022-09-20
10885862013750NAExactech, Inc.LPH2022-09-20
10885862022448NAExactech, Inc.LPH2022-09-19
10885862022448NAExactech, Inc.OQI2022-09-19
10885862022448NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.OQI2022-09-19
10885862022455NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.LPH2022-09-19
10885862029867NAExactech, Inc.LZO2022-09-19
10885862029867NAExactech, Inc.LPH2022-09-19
10885862034038NovationExactech, Inc.LZO2022-09-19
10885862034045NovationExactech, Inc.LZO2022-09-19
10885862034052NovationExactech, Inc.LZO2022-09-19
10885862034069NovationExactech, Inc.LZO2022-09-19
10885862034076NovationExactech, Inc.LZO2022-09-19
10885862034083NovationExactech, Inc.LZO2022-09-19
10885862034090NovationExactech, Inc.LZO2022-09-19
10885862034106NovationExactech, Inc.LZO2022-09-19
10885862034113NovationExactech, Inc.LZO2022-09-19
10885862033598NovationExactech, Inc.LZO2022-08-25
10885862033604NovationExactech, Inc.LZO2022-08-25
10885862033611NovationExactech, Inc.LZO2022-08-25
10885862033628NovationExactech, Inc.LZO2022-08-25
10885862033635NovationExactech, Inc.LZO2022-08-25
10885862033642NovationExactech, Inc.LZO2022-08-25
10885862033741NovationExactech, Inc.LZO2022-08-25
10885862033758NovationExactech, Inc.LZO2022-08-25
10885862033765NovationExactech, Inc.LZO2022-08-25
10885862010551NAExactech, Inc.LPH2022-08-18