FDA.reportPublic FDA data

Unity Total Knee System

Primary DI
05056139233722
Brand
Unity Total Knee System
Company
CORIN LTD
Model
1231050
Catalog number
1231050
Device description
Universal Impactor
Published
2018-09-20
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113060000UNITY TOATAL KNEE SYSTEMCorin USA2012-09-10JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056139233722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056139233722050561392337225056139233722

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.

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
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
00192629298675ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298682ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298699ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298705ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298712ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298729ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298736ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298743ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298750ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298767ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298774ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298781ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298798ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298804ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298811ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298828ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298835ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298842ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298859ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298866ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298873ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298880ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298897ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298903ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298910ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298927ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298934ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298941ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298958ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298965ProphecyMicroport Orthopedics Inc.JWH2020-09-25