FDA.reportPublic FDA data

Cormet

Primary DI
05055196905146
Brand
Cormet
Company
CORIN LTD
Model
179.052
Catalog number
179.052
Device description
Cormet resurfacing head - 52mm size 8 cemented
Published
2014-10-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXAProsthesis, Hip, Femoral, Resurfacing
NXTProsthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXAProsthesis, Hip, Femoral, ResurfacingOrthopedic2
NXTProsthesis, Hip, Semi-Constrained, Metal/Metal, ResurfacingUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994153000
P050016010

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994153000CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESISCorin USA2000-02-25KXA
P050016010CORMET HIP RESURFACING SYSTEMCorin USA2007-07-03NXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055196905146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055196905146050551969051465055196905146

GMDN Terms#

Term, Definition table
TermDefinition
Resurfacing metallic hip prosthesisAn implantable partial substitute for a disease-damaged hip joint intended to replace the articulating surfaces of the hip while preserving the natural femoral head and neck. It consists of a metallic femoral cap component, that is placed over (resurfaces) a surgically-prepared femoral head, and a metallic acetabular component; that is, both components are supplied together. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is commonly used for younger/active patients to avoid total hip replacements/revisions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
295437313
Device count
1
Lot or batch
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
09348215185541Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185558Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185565Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185572Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185589Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185596Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185602Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185619Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185626Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185633Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185640Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185657Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
00814193025654SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025661SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025678SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025685SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025692SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025708SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025715SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025722SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025753SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025739SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-01
00814193025746SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-01
00810068850383Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850390Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850406Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850413Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850420Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850437Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850444Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27