FDA.reportPublic FDA data

TRIFIT STEM

Primary DI
05055196963047
Brand
TRIFIT STEM
Company
CORIN LTD
Model
E090.125T
Catalog number
E090.125T
Device description
Tri-Fit Hip Stem
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
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010243000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010243000TRI-FIT FEMORAL STEMCorin USA2001-02-15LWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055196963047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055196963047050551969630475055196963047

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
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
10885862022448NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.LZO2022-09-19
10885862029867NAExactech, Inc.LZO2022-09-19
10885862029867NAExactech, Inc.LWJ2022-09-19
10885862034038NovationExactech, Inc.LWJ2022-09-19
10885862034038NovationExactech, Inc.LZO2022-09-19
10885862034045NovationExactech, Inc.LZO2022-09-19
10885862034045NovationExactech, Inc.LWJ2022-09-19
10885862034052NovationExactech, Inc.LWJ2022-09-19
10885862034052NovationExactech, Inc.LZO2022-09-19
10885862034069NovationExactech, Inc.LZO2022-09-19
10885862034069NovationExactech, Inc.LWJ2022-09-19
10885862034076NovationExactech, Inc.LZO2022-09-19
10885862034076NovationExactech, Inc.LWJ2022-09-19
10885862034083NovationExactech, Inc.LZO2022-09-19
10885862034083NovationExactech, Inc.LWJ2022-09-19
10885862034090NovationExactech, Inc.LWJ2022-09-19
10885862034090NovationExactech, Inc.LZO2022-09-19
10885862034106NovationExactech, Inc.LWJ2022-09-19
10885862034106NovationExactech, Inc.LZO2022-09-19
10885862034113NovationExactech, Inc.LWJ2022-09-19
10885862034113NovationExactech, Inc.LZO2022-09-19
10885862033598NovationExactech, Inc.LZO2022-08-25
10885862033598NovationExactech, Inc.LWJ2022-08-25
10885862033604NovationExactech, Inc.LWJ2022-08-25
10885862033604NovationExactech, Inc.LZO2022-08-25
10885862033611NovationExactech, Inc.LZO2022-08-25
10885862033611NovationExactech, Inc.LWJ2022-08-25
10885862033628NovationExactech, Inc.LWJ2022-08-25