Exactech’s Equinoxe® Scapula Reconstruction System Gains FDA Clearance for rTSA-Related Fracture Treatment

Exactech has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Equinoxe® Scapula Reconstruction System. 

This new system is designed specifically to support the treatment of acromial and scapular spine fractures, which are rare but serious complications that may occur following reverse total shoulder arthroplasty (rTSA).

These fractures, although uncommon, can be particularly difficult to treat. On average, they occur in around 2.8% of rTSA procedures, with some patient groups seeing rates as high as 10.9%. 

Despite their impact on patient outcomes, there has been no established solution for managing these fractures—until now.

In response to this clinical need, Exactech developed the Equinoxe Scapula Reconstruction System. It is the first trauma-specific plating solution created with rTSA-related complications in mind. 

It was designed in collaboration with a team of leading orthopaedic surgeons, each bringing significant experience with various shoulder implant systems.

This new system offers treatment options for fractures categorised under the Levy Type I, II, IIA and IIB classification, allowing for more individualised surgical strategies. 

It aims to restore function and improve outcomes for patients affected by this challenging complication.

The launch of the Equinoxe Scapula Reconstruction System represents a significant step forward in shoulder fracture care. 

It brings a much-needed, dedicated solution to the market and offers orthopaedic surgeons a more precise and effective way to manage these complex injuries following reverse shoulder replacements.