FDA.reportPublic FDA data

BioPoly® Great Toe Hemiarthroplasty Implant

Primary DI
00850012119388
Brand
BioPoly® Great Toe Hemiarthroplasty Implant
Company
Biopoly, LLC
Model
135-5114
Catalog number
135-5114
Device description
BioPoly® Great Toe Hemiarthroplasty Implant - 14mm Porous
Published
2022-02-04
Public version status
Update
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
KWDProsthesis, Toe, Hemi-, Phalangeal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWDProsthesis, Toe, Hemi-, PhalangealOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203634000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203634000BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC2021-02-02KWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012119388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012119388008500121193888500121193880850012119388

GMDN Terms#

Term, Definition table
TermDefinition
Partial metatarsophalangeal joint prosthesisA sterile implantable artificial substitute for the distal head of the metatarsal or the adjacent phalangeal base, intended to repair an articulating surface of the metatarsophalangeal (MTP) joint of the foot (toe). The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] and implantation may be performed with or without bone cement. The device is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter14Millimeter

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810005668095TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668101TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668118TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668187TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810135963565TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810135963572TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00850044114962Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635037Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635198Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635204Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635211Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635228Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635235Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635242Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635259Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635266Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635273Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635280Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635297Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635303Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635310Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635327Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635334Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635341Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635358Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850005618102BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618119BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618126BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618133BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618140BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25