AccessGUDID - DEVICE: ITOTAL-IPOLY-44MM X 11MM CEMENTED PATELLA IMPLANT (M572PAT0114411011)

GUDID

Device Identifier (DI) Information

Brand Name: ITOTAL-IPOLY-44MM X 11MM CEMENTED PATELLA IMPLANT
Version or Model: PAT011441101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PAT0114411
Company Name: Conformis, Inc.

Primary DI Number: M572PAT0114411011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808821883 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34199	Polyethylene patella prosthesis	An implantable device made of polyethylene (PE) intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attachment to the back of the natural patella with or without bone cement.	Active	true

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 [?]
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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 44MM X 11MM

Device Record Status

Public Device Record Key: c52006e2-3393-49ba-ab4a-8b778e53b1ce
Public Version Date: February 05, 2021
Public Version Number: 2
DI Record Publish Date: September 27, 2019