FDA.report

BioPoly® Radial Head Implant

Primary DI
00850005618263
Brand
BioPoly® Radial Head Implant
Company
Biopoly, LLC
Model
160-5086
Catalog number
160-5086
Device description
BioPoly® Radial Head Implant, 20 x 8(+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
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KWIProsthesis, Elbow, Hemi-, Radial, Polymer

Product Code Classifications

CodeDeviceSpecialtyClass
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2

Premarket Submissions

SubmissionSupplement
K233592000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K233592000BioPoly Radial Head ImplantBioPoly, LLC2024-03-13KWI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850005618263PrimaryGS10

GMDN Terms

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

Contacts

PhoneEmail
260-999-6135info@biopolyortho.com

Regulatory Flags

DUNS number
023778928
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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
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
00850005618492BioPoly® Radial Head Implant160-5376160-53762025-01-02
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00841506148953AlignSKELETAL DYNAMICS L.L.C.KWI2025-12-01
00841506148960AlignSKELETAL DYNAMICS L.L.C.KWI2025-12-01
00850005618034BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618041BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618058BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618065BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618072BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618089BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618249BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618256BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618287BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618294BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618461BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618478BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618485BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618492BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618508BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618522BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618539 BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618546BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618553BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618560BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618577BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618584BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618591BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618607BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618614BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618621BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618638BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618645BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02