FDA 510(k)

DYNAMIS Navigation System

K-Number: K252962 · 2026-01-12

Decision Date2026-01-12

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DYNAMIS Navigation System is a medical device manufactured by Promethean Restorative, LLC. It received FDA 510(k) clearance on 2026-01-12 under approval number K252962. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAMIS Navigation System?

DYNAMIS Navigation System is a medical device that received FDA 510(k) clearance on 2026-01-12. It is manufactured by Promethean Restorative, LLC. The 510(k) number is K252962.

When was DYNAMIS Navigation System approved by the FDA?

DYNAMIS Navigation System received FDA 510(k) clearance on 2026-01-12, under approval number K252962.

What company makes DYNAMIS Navigation System?

DYNAMIS Navigation System is manufactured by Promethean Restorative, LLC.

What is the FDA product code for DYNAMIS Navigation System?

The FDA product code for DYNAMIS Navigation System is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT06895187 Catheter Ablation Using a Novel Navigation and Imaging System NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Promethean Restorative, LLC

K251075DYNAMIS Implant System K243565DYNAMIS SI Screw System

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.