Regulatory

MagnetOs Flex Matrix bone graft is cleared by FDA as a bone void filler for use in the posterolateral spine.

Approval is based on results of a clinical study that demonstrated superiority of Agili-C to debridement and microfracture in the knee joint.

This is the second Breakthrough Designation for Theradaptive in spinal fusion, granted for the OsteoAdapt SP implant.

Proposed indications include filling of bony voids and gaps, and protecting against microbial colonization while granules resorb and are replaced with bone.

A critical component for bone development, magnesium contains high strength and a modulus of elasticity that closely resembles human bone.

This is the second-ever bone graft to achieve clearance for standalone use in the spine based on human clinical data.

The expanded FDA clearance applies to indications for use with NuVasive's thoracolumbar spinal interbody portfolio.

The injectable bone substitute is now FDA 510(k) cleared for augmenting suture anchor fixation.

The clearance follows existing clearances by the FDA for the use of MagnetOs Granules and MagnetOs Putty in the spine.

Maxx-PRP is a next-gen device to concentrate autologous whole blood for the safe and rapid preparation of platelet-rich plasma.