Latest medtech regulatory news

Exactech received 510(k) clearance of its Equinoxe Planning App (v. 2.0).

The latest version features:

• Ability to pre-operatively plan humeral implant options to model the best fit for each patient’s unique anatomy – select from a range of humeral stem components; adjust humeral head offset/ position in anatomic procedures; alter humeral trays, liners in reverse procedures

• Ability to assess shoulder range of motion, impingement

• Visual enhancements for clarity, ease of use

“Exactech is driven to create new solutions that enhance our surgeons’ surgical experiences,” says Chris Roche, Exactech’s senior vice president of extremities.

“The Equinoxe Planning App’s newest update helps surgeons plan and select various implant types and sizes for the scapula and humerus based on a patient’s specific boney morphology to facilitate planning of impingement- free movement.”

https://www.aisurgeon.com; https://www.exac.com

FDA clearance for two new plating lines

Gramercy Extremity Orthopedics (GEO) received FDA clearance of its distal fibular ankle fracture plating system and its Multi-Application Extremity Plating System (EPS).

“These new plates were designed to seamlessly integrate into our current system, using the same single-use sterile instrument kits and screws that we bring to market via the GEO Cart,” says GEO CTO, Paul Vasta. “The release of these new plating systems represents the continued expansion of GEO’s product line and highlights the unique benefits of the GEO Cart.”