3D’s Spline-Fix™ External Fixator System is the only known system of its kind with independent pin placement on a multi-pin clamp. It is capable of treating a variety of different fractures and was developed to address the shortcomings of existing fixators that are more limited in application. The Spline-Fix™ has the flexibility of treating a wide range of fractures throughout the body in both the trauma and limb reconstruction market. The device, made of titanium and applicable for long-bone and small-bone fractures, is based upon a ball collet pin clamp design that features a lengthening transport component which can be lengthened or shortened.
The Spline-Fix™ External Fixator provides unique versatility for the surgeon (independent pin placement on a multi-pin clamp), and is cost effective, strong, simple and easy to use. With its intuitive, light weight titanium construction, the Sline-Fix™ can undergo an MRI scan, which increases and is patient friendliness and clinical utility. It is classified as a Class II medical device and is currently undergoing the 510(k) regulatory process.