Of particular note is the creation of an alternative 510(k) pathway. First announced in September 2017, this fast-track method is designed for devices that may not meet the criteria for clearance under FDA's existing 510(k) program.
In examining the list of AAOS 2018 exhibitors, we observed that many are addressing needs "beyond the device"--think patient care, implant delivery and new ways to approach imaging in and out of the O.R.
IlluminOss Medical will enter the U.S. market in 2018 with its IlluminOss Bone Stabilization System, having received the first de novo clearance to be granted by FDA's orthopaedic panel. The de novo process provides a pathway to classify novel medical devices for which there is no legally marketed predicate device.
The company has acquired Zyga Technology, developer of the SImmetry® Sacroiliac Joint Fusion system. RTI Surgical's leadership cites the U.S. SI joint treatment market at ~$100MM, slated to exceed $200MM by 2024, with SI joint fusion procedures growing 20% annually.
Consensus Orthopedics' TracPatch (a wearable device that monitors patients pre- and post-op) is an example of a smaller company developing technology, outside of implantables and hardware, that is responding to the evidence-based medicine movement.
Implant failures can be avoided by embracing a comprehensive approach that combines design validation, failure analysis and explant testing. By proactively checking for potential and actual failures, you can gather data to make smarter design and manufacturing decisions.
