Cleared Special

MAVEN? Patient-Specific Instrumentation

K223227 · Paragon 28, Inc. · Orthopedic

Nov 2022

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K223227 is an FDA 510(k) clearance for the MAVEN? Patient-Specific Instrumentation, 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 November 17, 2022, 30 days after receiving the submission on October 18, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K223227 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2022
Decision Date	November 17, 2022
Days to Decision	30 days
Submission Type	Special
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