Cleared Traditional

TITAN 3-D Wedge System

K231496 · Paragon 28, Inc. · Orthopedic

Aug 2023

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K231496 is an FDA 510(k) clearance for the TITAN 3-D Wedge System, a Bone Wedge (Class II — Special Controls, product code PLF), submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on August 22, 2023, 90 days after receiving the submission on May 24, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K231496 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2023
Decision Date	August 22, 2023
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PLF — Bone Wedge
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030
Definition	Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia.