Cleared Special

Cadence Ankle PSI System

K243174 · 3D Systems, Inc. · Orthopedic
Oct 2024
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K243174 is an FDA 510(k) clearance for the Cadence Ankle PSI System, a Ankle Arthroplasty Implantation System (Class II — Special Controls, product code OYK), submitted by 3D Systems, Inc. (Littleton, US). The FDA issued a Cleared decision on October 25, 2024, 25 days after receiving the submission on September 30, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number K243174 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date October 25, 2024
Days to Decision 25 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OYK — Ankle Arthroplasty Implantation System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3110
Definition Intended To Be Used To Assist In The Implantation Of A Specific Ankle Arthroplasty Device. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, And Sizing.