WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K253249

510(k) cleared

TriALTIS Spine System

Medos International SARL · Oct 21, 2025 · K253249

FDA cleared the TriALTIS Spine System from Medos International SARL on Oct 21, 2025 under K253249, a special 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 29, 2025. The decision came 22 days later, inside the 90 FDA-day goal for a 510(k).

Medos International SARL has 2 other decisions in the tracker over the last 12 months: K254157 (CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody), K260240 (SYMPHONY Navigation Ready Instruments).

Questions & Answers

What did FDA clear under K253249?

K253249 is the FDA 510(k) for TriALTIS Spine System, submitted by Medos International SARL. FDA's decision date was Oct 21, 2025, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the TriALTIS Spine System?

Medos International SARL, based in Le Locle, is the applicant of record for K253249.

How long did the K253249 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Oct 21, 2025, 22 days later.

← All decisions in October 2025

Sources