AccessGUDID - DEVICE: Triathlon (07613327049893)

GUDID

Device Identifier (DI) Information

Brand Name: Triathlon
Version or Model: 5554-L-320
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5554-L-320
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327049893
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: Metal Backed Patella

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:	Yes
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

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

GMDN Preferred Term Name	GMDN Definition
Metal-backed patella prosthesis	An artificial kneecap (patellar component) covered with metal on its outer surface and implanted during primary or revision bicondylar knee joint replacement. It is a sterile device designed to articulate with a prosthetic distal femoral component and is implanted on the back of the natural patella with or without bone cement.

FDA Product Code

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Product Code	Product Code Name
MBH	PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Diameter: 32.0 Millimeter
Device Size Text, specify: Type: Asymetric
Device Size Text, specify: Thickness: 10.0 Millimeter

Device Record Status

Public Device Record Key: e13989f4-c7f2-4d34-a633-e3f1adde1fea
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2015