DEVICE: Triathlon (07613327049893)
Device Identifier (DI) Information
Triathlon
5554-L-320
In Commercial Distribution
5554-L-320
Howmedica Osteonics Corp.
5554-L-320
In Commercial Distribution
5554-L-320
Howmedica Osteonics Corp.
Metal Backed Patella
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]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
[?]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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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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
e13989f4-c7f2-4d34-a633-e3f1adde1fea
March 29, 2018
2
September 24, 2015
March 29, 2018
2
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined