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FDA 510(k)

DYNAMIS™ Implant System

K-Number: K251075 · 2025-04-25

ApplicantPromethean Restorative, LLC
Decision Date2025-04-25
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYNAMIS™ Implant System is a medical device manufactured by Promethean Restorative, LLC. It received FDA 510(k) clearance on 2025-04-25 under approval number K251075. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAMIS™ Implant System?

DYNAMIS™ Implant System is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Promethean Restorative, LLC. The 510(k) number is K251075.

When was DYNAMIS™ Implant System approved by the FDA?

DYNAMIS™ Implant System received FDA 510(k) clearance on 2025-04-25, under approval number K251075.

What company makes DYNAMIS™ Implant System?

DYNAMIS™ Implant System is manufactured by Promethean Restorative, LLC.

What is the FDA product code for DYNAMIS™ Implant System?

The FDA product code for DYNAMIS™ Implant System is OUR.

Related Clinical Trials

NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING NCT07287124 A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults RECRUITING

Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Promethean Restorative, LLC

K243565DYNAMIS™ SI Screw System K252962DYNAMIS™ Navigation System

Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

Official Source

View on FDA Database →

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

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