AccessGUDID - DEVICE: Katalyst™ Bipolar Radial Head System (10381780065791)

GUDID

Device Identifier (DI) Information

Brand Name: Katalyst™ Bipolar Radial Head System
Version or Model: 221421
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 221421
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780065791
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: The Katalyst Radial Head restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation.

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?
33701	Elbow radius prosthesis	A sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032806	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
Special Storage Condition, Specify: Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 21 mm dia x 8.73 mm depth

Device Record Status

Public Device Record Key: 2ec5e00e-c866-4c26-bb01-615e9c7f5ed1
Public Version Date: February 21, 2023
Public Version Number: 7
DI Record Publish Date: October 09, 2017