The FDA cleared the use of K2M's screw and connector components for its Mesa Spinal System.
Here are five key points:
1. Surgeons may now use the screw and connector components as part of a growing rod construct for patients under 10 years old.
2. The company's growing spine system is intended to obtain and maintain correction of severe, progressive and life-threatening early-onset spinal deformities.
3. The technology provides growth guidance as well, with standard instrumentation and placement of unlocked closed-head screws at non-fusion levels, allowing for rod passage as the patient grows.
4. Surgeons may use the growth guidance implants with any K2M rode construct with diameters between 4.5 mm and 6.35 mm. The growth rod conversion implants comply with 4.5 mm and 5.5 mm rod constructs.
5. K2M announced the FDA clearance at the Scoliosis Research Society's 51st Annual Meeting & Course in Prague, Czech Republic.