DEVICE: RESTORIS (00848486000424)

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Device Record History
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Device Identifier (DI) Information
RESTORIS
180404
In Commercial Distribution
180404
MAKO SURGICAL CORP.
00848486000424
GS1

1
175239677 *Terms of Use
MCK Patellofemoral Component
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Device Characteristics
MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58227 Patellofemoral joint prosthesis
A sterile implantable device designed to replace the patellofemoral articulating surface of the knee to treat isolated patellofemoral disease, typically osteoarthritis. The device is made of metal (e.g., oxidized zirconium alloy) and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; it may include fixation devices (e.g., pegs) for implantation which is intended to be performed with bone cement.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HRY PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
KRR PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HSX PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
NPJ PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K082172 000
K090763 000
K150307 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Size: 4
Device Size Text, specify: Side: LEFT
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Device Record Status
1d2bcfb8-6591-4355-aa54-0766ab9d1091
August 19, 2022
4
September 24, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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