RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children

NANot yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Fracture Fixation, InternalDistal Radius Fracture
Interventions
DEVICE

Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children

This is a first-in-child clinical investigation of a bioresorbable magnesium alloy DrillPin (RemeOs™) for fixation of distal radius fractures in children aged 5 to \<14 years. The implant is investigational, not CE-marked or FDA-approved, and represents a novel alternative to traditional metallic implants. It gradually degrades in vivo, eliminating the need for removal. The study focuses on safety and feasibility in a pediatric population, supported by preclinical data from a similar Mg-based RemeOs™ Screw. The DrillPin's material and design are intended to support bone healing without growth disturbances, offering a state-of-the-art, bioresorbable solution tailored for growing patients.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bioretec Ltd.

INDUSTRY