Katalyst™ Bipolar Radial Head System

Basic Information

• Brand Name: Katalyst™ Bipolar Radial Head System
• Primary DI: 10381780065876
• Version / Model: 221685
• Catalog Number: 221685
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Labeler DUNS: 963856096
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 4
• Public Version Date: 2021-02-26
• Public Version Status: Update
• Public Device Record Key: 228998dd-50f1-449a-bc61-921459b04da4

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	888.3170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2482216851	HIBCC
Primary	10381780065876	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K032806	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8.5 mm dia x 31 mm L

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.