Search Results

The K2M Growing Spine System implants are indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The Growth Guidance implants may be used with any cleared K2M rod construct ranging in diameter 4.5mm to 6.35mm. The Growth Rod Conversion implants may be used with 4.5mm and 5.5mm rod constructs. The K2M Growing Spine System is not intended to be used in conjunction with staples.

The K2M Growing Spine System consists of screw and connector components. The purpose of this 510(k) is to enable these system components to be used as part of a growing rod construct.

Function: When used as part of a growing rod construct, the system implants are designed to accommodate growth in patients under 10 years of age.

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study proving it, or the other requested details such as sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) premarket notification letter from the FDA regarding the K2M Growing Spine System, indicating its substantial equivalence to predicate devices and detailing its intended use. It does not include specific performance metrics, studies, or clinical trial data in the format you've requested.

Ask a specific question about this device