Cleared Special

K253249 - TriALTIS Spine System

K253249 is the FDA 510(k) clearance for TriALTIS Spine System by Medos International SARL. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 22-day FDA review.

K253249 · Medos International SARL · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
22d
Days
Class 2
Risk

K253249 is an FDA 510(k) clearance for the TriALTIS™ Spine System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on October 21, 2025 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medos International SARL devices

Submission Details

510(k) Number K253249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Pioneer Surgical Technologies, Inc.
Sravya Lahari Sripada

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K253249.
Fule Spinal Fixation System
K252730 · Beijing Fule Science & Technology Development Co., Ltd. · Oct 2025
CD Horizon™ Spinal System
K253335 · Medtronic Sofamor Danek USA, Inc. · Oct 2025
OLYMPIC Posterior Spinal Fixation System
K252346 · Astura Medical · Oct 2025
A8 INTEGR8™ Porous Pedicle Screws
K242827 · Allumin8, Inc. · Oct 2025
PressON Spinal Fixation System
K253331 · Nexus Spine · Oct 2025
JAZZ Spinal System
K252437 · Implanet · Aug 2025