Globus Medical debuted its FDA-510(k)-cleared trauma products in four families, including fracture plates, compression screws, cannulated screws, intramedullary nails and external fixation. As noted in the company's 4Q17 earnings call, full launch of all systems will commence in 2Q18.
The eleven FDA-cleared products, which address upper and lower extremities and hip and long bones, are:
- Proximal Humerus Plating System for shoulder fractures, with variable angle calcar screws and radiolucent instruments
- Clavicle Plating System with plate contours optimized for clinically-based fracture zones
- Comprehensive Distal Radius Fracture System for wrist fractures with volar, dorsal and lateral plates as well as a robust bridge plate
- Proximal Tibia Plating System with triple kick-stand screw fixation, integrated polyaxial rafting screws and a radiolucent aiming arm for percutaneous fixation
- Comprehensive Ankle Fracture System including distal Fibula plates, Cannulated Screws and Small Fragment Plating components
- Small Fragment Plating System for general fractures with locking and non-locking implants and radiolucent instruments
- External Fixator System enabling fracture stabilization using one style clamp and one instrument
- Tibial Nailing System offering infra- and supra-patellar approaches and locking options
- Trochanteric Nailing System for geriatric hip fracture reduction and fixation
- Comprehensive Femoral Nailing System with Recon screw options in Piriformis and Troch-entry style nails
- Comprehensive Compression Screw System for general fracture care, including headless screws and a variable-length family of screws to address tough-to-reduce fractures or limited bone purchase scenarios
Sources: Globus Medical, Inc.; ORTHOWORLD Inc.