FDA: Test ‘Worst-Case’ Version of Intervertebral Body Fusion Devices

Manufacturers of intervertebral body fusion devices containing bone-grafting material should test constructs representing the worst-case (e.g., most likely to fail) final design version, the FDA says in a recent guidance document.

Information on this testing should be included in 510(k) applications for this type of device, the agency says. Companies should also provide their rationales for selecting particular constructs as the worst case. Components tested should comprise worst-case constructs in terms of design, materials and manufacturing-related processing.

The Center for Devices and Radiological Health’s Orthopedic Spine Devices Branch is available to answer questions about testing setups, identification of a worst-case construct or additional testing for a device, the guidance adds.

The guidance was issued to support reclassification of intervertebral body fusion devices containing bone-grafting material into Class II (special controls) from Class III (premarket approval). Intervertebral body fusion devices are implanted single or multiple-component spinal devices made from a variety of materials, including titanium and polymers.

The document provides recommendations for abbreviated 510(k) applications for these devices. The FDA believes abbreviated 510(k)s provide the least burdensome means of demonstrating substantial equivalence for new devices.

The guidance, “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device,” can be viewed at www.fda.gov/cdrh/ode/guidance/1540.pdf.