Cleared Traditional

APEX 3D Total Ankle Replacement System

K240259 · Paragon 28, Inc. · Orthopedic

Jun 2024

Decision

145d

Days

Class 2

Risk

About This 510(k) Submission

K240259 is an FDA 510(k) clearance for the APEX 3D Total Ankle Replacement System, a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSN), submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on June 24, 2024, 145 days after receiving the submission on January 31, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K240259 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2024
Decision Date	June 24, 2024
Days to Decision	145 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3110