GRUVE + Cervical plating system; Stratasys Direct achieves ISO 13485 certification

Life Spine Inc. received U.S. Food & Drug Administration (FDA) 501(k) clearance to market the GRUVE + Cervical Plating System, establishing a new standard in spinal surgery through its advanced design and seamless integration with Life Spine’s cervical spacers. Engineered for versatility and precision, it addresses the diverse needs of surgeons and patients, enhancing surgical efficiency and outcomes.

Key features and benefits:

• Streamlined plate-cage attachment: Flexible connection in-situ or prior to insertion
• Specialized sub-flush design: Accommodates osteophytes for improved comfort
• Customizable plate options: Two-hole and four-hole configurations for anatomical preferences
• Self-drilling/self-tapping screws: High angulation trajectory for varied anatomies
• CAM locking mechanism: Triple feedback (visual, tactile, audible) to secure screws and prevent back-out
• Compatibility: Integrates with PLATEAU-C/PLATEAU-C Ti and Pro-Link/Pro-Link Ti platforms
• Large graft window: Maximizes material containment for robust fusion

Stratasys Direct earns ISO 13485 certification

Stratasys Ltd.’s Stratasys Direct manufacturing facility in Tucson, Arizona achieved ISO 13485 certification, a globally recognized standard for quality management systems in medical device manufacturing. Stratasys plans to extend this certification to its other Stratasys Direct manufacturing facilities in Texas and Minnesota.

By achieving ISO 13485 certification, Stratasys Direct is formally recognized for the safety, precision, and reliability of its 3D-printed components. This certification addresses critical regulatory requirements, removing barriers to adoption and enabling medical device manufacturers to scale production reliably while accelerating innovation, reducing costs, and improving patient outcomes.

Stratasys Direct 3D prints multiple components for the medical industry making complex geometries and patient-specific components that traditional methods cannot achieve.