Cleared Traditional

APEX 3D Total Ankle Replacement System

K250641 · Paragon 28, Inc. · Orthopedic

May 2025

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K250641 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 May 1, 2025, 58 days after receiving the submission on March 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K250641 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2025
Decision Date	May 01, 2025
Days to Decision	58 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