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 / January 2026 / K252962

510(k) cleared

DYNAMIS Navigation System

Promethean Restorative, LLC · Jan 12, 2026 · K252962

FDA cleared the DYNAMIS Navigation System from Promethean Restorative, LLC on Jan 12, 2026 under K252962, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 16, 2025. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Promethean Restorative, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252962?

K252962 is the FDA 510(k) for DYNAMIS Navigation System, submitted by Promethean Restorative, LLC. FDA's decision date was Jan 12, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the DYNAMIS Navigation System?

Promethean Restorative, LLC, based in Castle Rock, CO, is the applicant of record for K252962.

How long did the K252962 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on Jan 12, 2026, 118 days later.

← All decisions in January 2026