AccessGUDID - DEVICE: iTotal® iPoly XE™ Patella (M572PAT0213206011)

GUDID

Device Identifier (DI) Information

Brand Name: iTotal® iPoly XE™ Patella
Version or Model: PAT021320601
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PAT0213206
Company Name: Conformis, Inc.

Primary DI Number: M572PAT0213206011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808821883 *Terms of Use

Device Description: N/A

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
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142161	000

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
Outer Diameter: 32 Millimeter

Device Record Status

Public Device Record Key: c0b0f343-d35a-4c95-b94d-ffbf4407ca12
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: October 26, 2015