Cleared Traditional

BioPoly Radial Head Implant

K233592 · BioPoly, LLC · Orthopedic
Mar 2024
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K233592 is an FDA 510(k) clearance for the BioPoly Radial Head Implant, a Prosthesis, Elbow, Hemi-, Radial, Polymer (Class II — Special Controls, product code KWI), submitted by BioPoly, LLC (Fort Wayne, US). The FDA issued a Cleared decision on March 13, 2024, 126 days after receiving the submission on November 8, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3170.

Submission Details

510(k) Number K233592 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2023
Decision Date March 13, 2024
Days to Decision 126 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3170

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