X-Bolt Orthopedics Inc.
Medical device company focused on orthopedic fixation devices for hip and spine. Develops expandable in‑situ anchorage implants and associated instrumentation, conducts biomechanical testing and large multicenter randomized clinical trials, and maintains regulatory clearances and quality certification for commercialization.
Industries
N/A
Nr. of Employees
small (1-50)
X-Bolt Orthopedics Inc.
Unit 5 Northwood Court, Santry, Dublin D09 AX54, Ireland
Products
Pro-X1 Trochanteric Nail
Trochanteric nailing system designed for fixation of extracapsular hip fractures featuring an expandable anchorage mechanism and instrumentation intended to simplify implantation and reduce common causes of reoperation.
XHS Femoral Neck Plating
Femoral neck plating system with an actuated expandable element intended to provide rotational stability and single-device fixation for certain proximal femur fractures.
Spinal DragonBolt (expandable pedicle concept)
Expandable pedicle fixation concept for spine intended to deploy an anchorage element with reversible deployment to improve purchase in vertebral bone and avoid cement augmentation.
Pro-X1 Trochanteric Nail
Trochanteric nailing system designed for fixation of extracapsular hip fractures featuring an expandable anchorage mechanism and instrumentation intended to simplify implantation and reduce common causes of reoperation.
XHS Femoral Neck Plating
Femoral neck plating system with an actuated expandable element intended to provide rotational stability and single-device fixation for certain proximal femur fractures.
Spinal DragonBolt (expandable pedicle concept)
Expandable pedicle fixation concept for spine intended to deploy an anchorage element with reversible deployment to improve purchase in vertebral bone and avoid cement augmentation.
Expertise Areas
- Clinical trial management and evidence generation
- Orthopedic implant engineering and device design
- Biomechanical testing and device validation
- Regulatory submissions and quality management (FDA 510(k), ISO 13485)
Key Technologies
- Expandable in-situ anchorage mechanisms
- Trochanteric nailing systems
- Femoral neck plating systems
- Expandable pedicle screw concepts
News & Updates
Completion of one-year follow-up for the 1000th patient in a multicenter randomized controlled trial (WHITE4) comparing extracapsular hip fracture fixation devices.
FDA 510(k) clearance(s) obtained to market hip nailing and hip plating fixation systems in the United States (clearance number K181640 referenced).
Single-centre randomized pilot study reported 0% re-operation rate for the expandable fixation device versus 6.8% for sliding hip screw in unstable A2/A3 fractures (Bone & Joint Journal 2016).
Certificate of registration to ISO 13485:2016 for quality management systems (NSAI certificate dated 19 Sept 2023).
Received 'Best Technology in Spine' award reported on company news page.
Completion of one-year follow-up for the 1000th patient in a multicenter randomized controlled trial (WHITE4) comparing extracapsular hip fracture fixation devices.
FDA 510(k) clearance(s) obtained to market hip nailing and hip plating fixation systems in the United States (clearance number K181640 referenced).
Single-centre randomized pilot study reported 0% re-operation rate for the expandable fixation device versus 6.8% for sliding hip screw in unstable A2/A3 fractures (Bone & Joint Journal 2016).
Certificate of registration to ISO 13485:2016 for quality management systems (NSAI certificate dated 19 Sept 2023).
Received 'Best Technology in Spine' award reported on company news page.