BioPoly Great Toe Hemiarthroplasty Implant

Q: What is the product code of K203634?

The FDA product code is KWD – Prosthesis, Toe, Hemi-, Phalangeal, a Class II (moderate risk) device regulated under 21 CFR 888.3730.

FDA 510(k) K203634 · BioPoly, LLC

Substantially Equivalent

510(k) numberK203634

Submission

Device name: BioPoly Great Toe Hemiarthroplasty Implant
Applicant: BioPoly, LLC
Fort Wayne, IN, US
Received: December 11, 2020
Decision date: February 2, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KWD – Prosthesis, Toe, Hemi-, Phalangeal
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3730
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code KWD

510(k)	Device	Applicant	Decision
K250074	HYALEX® MTP Hemiarthroplasty ImplantKWD · Traditional	Hyalex Orthopaedics, Inc.	04/03/2026SE
K240268	Accu-Joint Hemi ImplantKWD · Special	Accufix Surgical, Inc.	02/29/2024SE
K221220	Montross Extremity Medical Hemi Implant SystemKWD · Traditional	Montross Extremity Medical	04/19/2023SE
K222964	BioPoly Lesser Toe Hemiarthroplasty ImplantKWD · Traditional	BioPoly, LLC	11/22/2022SE
K201393	restor3d MTP ImplantKWD · Traditional	Restor3D, Inc.	05/25/2022SE
K200951	Accu-Joint Hemi ImplantKWD · Traditional	Accufix Surgical, Inc.	12/08/2020SE
K190261	BOSS Toe Fixation SystemKWD · Traditional	Arthrosurface, Inc.	08/14/2019SE
K190543	Cannulated Hemi ImplantKWD · Traditional	Vilex IN Tennessee, Inc.	05/31/2019SE
K161279	Life Spine Metatarsal Hemi ImplantKWD · Traditional	Life Spine, Inc.	02/01/2017SE
K152454	HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemKWD · Special	Arthrosurface, Inc.	04/11/2016SE

More from Arthrosurface, Inc.

510(k)	Device	Decision
K233592	BioPoly Radial Head ImplantKWI · Traditional	03/13/2024SE
K222964	BioPoly Lesser Toe Hemiarthroplasty ImplantKWD · Traditional	11/22/2022SE

Questions and answers

When was BioPoly Great Toe Hemiarthroplasty Implant cleared by the FDA?

BioPoly Great Toe Hemiarthroplasty Implant (K203634) received a 510(k) decision of Substantially Equivalent on February 2, 2021, 53 days after the submission was received.

What is the product code of K203634?

The FDA product code is KWD – Prosthesis, Toe, Hemi-, Phalangeal, a Class II (moderate risk) device regulated under 21 CFR 888.3730.