Cleared Traditional

Salto Talaris Ankle PSI System

K241148 · 3D Systems, Inc. · Orthopedic
Aug 2024
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K241148 is an FDA 510(k) clearance for the Salto Talaris 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 August 30, 2024, 127 days after receiving the submission on April 25, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number K241148 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2024
Decision Date August 30, 2024
Days to Decision 127 days
Submission Type Traditional
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.