FDA.reportPublic FDA data

Unity Total Knee System

Primary DI
05055343886830
Brand
Unity Total Knee System
Company
CORIN LTD
Model
A123.350.00
Catalog number
A123.350.00
Device description
Pin Driver (AO)
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
05055343886830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055343886830050553438868305055343886830

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+441285659866lucinda.gerber@coringroup.com
+441285659866rachel.king@coringroup.com

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
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
05056139245794Apollo KneeTKR.BB.11022025-04-07
05056139245800Apollo KneeTKR.BB.11032025-04-07
05056139245817Apollo KneeTKR.BB.12002025-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017262819EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262826EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262833EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262840EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262857EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262864EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262871EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262888EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262895EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262901EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262918EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262925EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262932EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262949EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262956EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262963EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262970EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262987EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262994EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263007EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263014EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263021EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263038EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263045EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263052EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263069EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263076EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263083EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263090EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263106EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10