AccessGUDID - DEVICE: Unity Total Knee System (05055343891537)

GUDID

Device Identifier (DI) Information

Brand Name: Unity Total Knee System
Version or Model: 123.081.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 123.081.00
Company Name: CORIN LTD

Primary DI Number: 05055343891537
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 295437313 *Terms of Use

Device Description: Ligament Balancer Extension Attachment

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Orthopaedic knee-balance analyser	A mechanical orthopaedic measuring/testing instrument used by a surgeon during the procedure to interrogate the strength and integrity of the ligaments that support (balance) the knee, prior to bony resection for a total knee arthroplasty (TKA). This may provide information essential to the selection of an optimal type of knee prosthesis. It is typically a spring-loaded device with dual-force scales that uses integral paddles to push against the rejected tibia and unresected femoral condyles. The surgeon can increase the force applied and obtain readings from the scales. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic knee-balance analyser

A mechanical orthopaedic measuring/testing instrument used by a surgeon during the procedure to interrogate the strength and integrity of the ligaments that support (balance) the knee, prior to bony resection for a total knee arthroplasty (TKA). This may provide information essential to the selection of an optimal type of knee prosthesis. It is typically a spring-loaded device with dual-force scales that uses integral paddles to push against the rejected tibia and unresected femoral condyles. The surgeon can increase the force applied and obtain readings from the scales. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113060	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ec397f3b-fce1-403e-984d-a5db2878c1e9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 17, 2016