BioPoly® Radial Head Implant

Basic Information

• Brand Name: BioPoly® Radial Head Implant
• Primary DI: 00850005618256
• Version / Model: 160-5083
• Catalog Number: 160-5083
• Company Name: Biopoly, LLC
• Labeler DUNS: 023778928
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-02
• Public Version: 1
• Public Version Date: 2025-01-10
• Public Version Status: New
• Public Device Record Key: cf90defa-ce23-4ce0-a5fe-577919ae7ed4

Device Description

BioPoly® Radial Head Implant, 20 x 8(+3)mm

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: No
• 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
Primary	00850005618256	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K233592	000