Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008108789

FEI Number

3008108789

Entity Name

BIOPOLY, LLC

City/State/Country

Fort Wayne, IN, US

Establishment Address

7136 Gettysburg Pike, Fort Wayne, IN 46804, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioPoly, LLC (Owner Number: 10041050)

Owner / Operator Contact Address

7136 Gettysburg Pike, Fort Wayne, IN 46804, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233592

PMA Number

N/A

All Registered Proprietary Names

BioPoly® Radial Head Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2024-12-27

Official Correspondent

Herb Schwartz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioPoly, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2023	Wright Medical Technology, Inc.	2	stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
Z-0006-2023	Wright Medical Technology, Inc.	2	stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.

Similar Registrations

Registration Number	Establishment Name	Location
3010667733	WRIGHT MEDICAL TECHNOLOGY, INC.	Memphis, TN, US
1649518	Sterigenics US LLC	Fort Worth, TX, US
3015207155	Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai, CN
1226544	MILLSTONE MEDICAL OUTSOURCING LLC.	FALL RIVER, MA, US
1526534	Sterigenics US, LLC	Lewis Center, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008108789. Last updated year: 2026. Please use registration number 3008108789 when referencing this establishment in official correspondence.