Accredited Testing Services for your bone screws, plates, pins and rods
Internal fixation offers an ideal alternative to traditional casts and splints. In fact, the American Academy of Orthopaedic Surgeons (AAOS) states members ranked “the development of internal fixation…high on the list” of significant treatment advances during the 20th century.
Mechanical Testing of Fixation Devices
With the plethora of spinal fixation devices available on the market, mechanical testing is a crucial component for proving equivalence or superiority to a predicate device when seeking regulatory approval.
Or perhaps your device is so unique and innovative that no applicable standard exists – and you need a custom test protocol and fixturing developed by an accredited, experienced laboratory.
Accutek can help you achieve your testing goals. Our breadth of understanding in managing standard ASTM tests and developing custom protocols will provide you with a clear perspective for your testing program in a timely, cost-effective manner. Accutek’s previous experience in testing many different spinal fixation systems and their individual components is also a substantial resource for you in early identification of factors to watch during testing.
Typical Devices Tested
- Bone plates
- Bone screws
- Intermedullary Rods and Nails
- Spinal Fixation Assemblies
Common Test Specifications
- ASTM F382 - Metallic Bone Plates
- ASTM F543 - Metallic Bone Screws
- ASTM F564 - Metallic Bone Staples
- ASTM F1717 - Spinal Implant Constructs
- ASTM F1798 – Implant Interconnection mechanisms
- ASTM F384 – Angled Metallic Bone Plates
- ASTM F2193 – Metallic Bone Plates and Screws
- ASTM F2706 – Occipital-Cervical and Occipital-Cervical-Thoracic spinal implant constructs