K2M receives FDA clearance for pediatric spinal deformity system components: 5 key points

The FDA cleared the use of K2M’s screw and connector components for its Mesa Spinal System.

Advertisement

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.

 

More articles on devices:
Choosing the empowered patient for outpatient TJRs — Baptist Health South Florida’s Dr. Alexander van der Ven weighs in
5 largest segments in orthopedics by product sales: Joint reconstruction has 35%
Carestream’s cone beam CT system receives FDA clearance: 4 things to know

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.

Advertisement

Next Up in Spinal Tech

Advertisement

Comments are closed.