Cleared Special

TriALTIS? Spine System

K253249 · Medos International SARL · Orthopedic

Oct 2025

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K253249 is an FDA 510(k) clearance for the TriALTIS? Spine System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on October 21, 2025, 22 days after receiving the submission on September 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K253249 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2025
Decision Date	October 21, 2025
Days to Decision	22 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.