Foundation Surgical Earns 510(k) for Navigated Lateral Disc Preparation Instruments

Foundation Surgical received FDA 510(k) clearance to market its Navigated Lateral Disc Preparation instrument system.

The platform is designed for compatibility with established intraoperative imaging and navigation technologies, including Medtronic’s O-Arm imaging system and StealthStation navigation platform.

The Interwedge system includes a comprehensive suite of navigated instruments intended to support disc space preparation and instrumentation during lateral procedures, including:

• Navigated Lateral Disc Preparation Instruments: Trials, paddle shavers, osteotomes, and Cobb elevators
• Navigated Screw Instrumentation: Taps and awls
• Navigation-Enabled Access Instruments: Probes and dilator compatible with StealthStation workflows

The system enables real-time intraoperative visualization during key procedural steps, supporting accuracy and consistency without requiring changes to existing operating room workflows. The addition of navigated instrumentation addresses growing demand for increased visualization and control during lateral spine procedures, particularly during disc preparation and implant placement.

Source: Foundation Surgical

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