Cleared Traditional

BioPoly Lesser Toe Hemiarthroplasty Implant

K222964 · BioPoly, LLC · Orthopedic

Nov 2022

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K222964 is an FDA 510(k) clearance for the BioPoly Lesser Toe Hemiarthroplasty Implant, a Prosthesis, Toe, Hemi-, Phalangeal (Class II — Special Controls, product code KWD), submitted by BioPoly, LLC (Fort Wayne, US). The FDA issued a Cleared decision on November 22, 2022, 56 days after receiving the submission on September 27, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3730.

Submission Details

510(k) Number	K222964 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2022
Decision Date	November 22, 2022
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF