AccessGUDID - DEVICE: iUni® Unicondylar Knee Replacement System (M572UKA1111111011)

GUDID

Device Identifier (DI) Information

Brand Name: iUni® Unicondylar Knee Replacement System
Version or Model: UKA111111101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: UKA1111111
Company Name: Conformis, Inc.

Primary DI Number: M572UKA1111111011
Issuing Agency: HIBCC
Commercial Distribution End Date: August 15, 2022
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?	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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34195	Unicondylar knee prosthesis	A sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OOG	Knee Arthroplasty Implantation System
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132640	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
Device Size Text, specify: Patient Specific

Device Record Status

Public Device Record Key: 71828173-8059-4d2d-ac22-a03204fbbce8
Public Version Date: August 16, 2022
Public Version Number: 4
DI Record Publish Date: October 26, 2015