FDA.reportPublic FDA data

BioPoly® Radial Head Implant

Primary DI
00850005618492
Brand
BioPoly® Radial Head Implant
Company
Biopoly, LLC
Model
160-5376
Catalog number
160-5376
Device description
BioPoly® Radial Head Implant, 23 x 7(+6)mm
Published
2025-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWIProsthesis, Elbow, Hemi-, Radial, Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233592000BioPoly Radial Head ImplantBioPoly, LLC2024-03-13KWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005618492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005618492008500056184928500056184920850005618492

GMDN Terms#

Term, Definition table
TermDefinition
Elbow radius prosthesisA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
260-999-6135info@biopolyortho.com

Regulatory Flags#

DUNS number
023778928
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005618034BioPoly® Radial Head Implant160-5060160-50602025-01-02
00850005618041BioPoly® Radial Head Implant160-5063160-50632025-01-02
00850005618058BioPoly® Radial Head Implant160-5066160-50662025-01-02
00850005618065BioPoly® Radial Head Implant160-5070160-50702025-01-02
00850005618072BioPoly® Radial Head Implant160-5073160-50732025-01-02
00850005618089BioPoly® Radial Head Implant160-5076160-50762025-01-02
00850005618249BioPoly® Radial Head Implant160-5080160-50802025-01-02
00850005618256BioPoly® Radial Head Implant160-5083160-50832025-01-02
00850005618263BioPoly® Radial Head Implant160-5086160-50862025-01-02
00850005618287BioPoly® Radial Head Implant160-5360160-53602025-01-02
00850005618294BioPoly® Radial Head Implant160-5363160-53632025-01-02
00850005618461BioPoly® Radial Head Implant160-5366160-53662025-01-02
00850005618478BioPoly® Radial Head Implant160-5370160-53702025-01-02
00850005618485BioPoly® Radial Head Implant160-5373160-53732025-01-02
00850005618508BioPoly® Radial Head Implant160-5380160-53802025-01-02
00850005618522BioPoly® Radial Head Implant160-5383160-53832025-01-02
00850005618539 BioPoly® Radial Head Implant160-5386160-53862025-01-02
00850005618546BioPoly® Radial Head Implant160-5390160-53902025-01-02
00850005618553BioPoly® Radial Head Implant160-5393160-53932025-01-02
00850005618560BioPoly® Radial Head Implant160-5396160-53962025-01-02

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Primary DI, Brand, Company table
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00888867568082Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568099Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568129Arthrex®ARTHREX, INC.KWI2026-09-17
00885556827307Katalyst Bipolar Radial Head SystemSmith & Nephew, Inc.KWI2022-12-21
00885556827314Katalyst Bipolar Radial Head SystemSmith & Nephew, Inc.KWI2022-12-21
00885556827338Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.KWI2022-12-21
00885556827345Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.KWI2022-12-21
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