Additive Implants Receives FDA Clearance for SureMAX-X Cervical Spacer

Additive Implants, Inc. received regulatory clearance to market in the US its second product, the SureMAX-X Cervical Spacer. This 3D printed titanium spacer has a unique patented design to create uniform end plate coverage and optimize load distribution.
 
“Maximizing implant coverage of the endplates and providing for more uniform load distribution is important to minimizing implant subsidence. We accomplished this objective through a number of differentiated features on the spacer, including the posterior window and the eyebrow holes on the anterior surface,” said Bob Brosnahan, COO of Additive Implants.
 
The roughened porous and convex shaped surfaces maximize contact with the bony endplates. Large lateral windows facilitate radiographic confirmation of healing.
 
SureMAX-X offers an industry-leading range of implant sizes; 7º, 10º and 14º lordotic and hyperlordotic angles with footprints of 12 x 14mm, 14 x 16mm, 15 x 18mm, and 15 x 20mm in heights of 5, 6, 7, 8, and 9mm.
 
“By using Euler’s Column Theory and limiting the implant’s height to 9mm, we were able to make SureMAX-X less stiff than other titanium spacers,” said Brosnahan.
 
While in contrast, the SureMAX Cervical Spacer, Additive Implants’ first product launch, is more focused on bone implant interface and overall stability.
 
“We felt it was important for us as a company to offer choices of not just sizes but also design philosophies,” said Jeff Horn, VP Commercialization of Additive Implants. “We wanted surgeons to have multiple options to deliver the best surgical outcomes based on their technique preferences; whether they use Caspar pins, do bone sparing surgery or thoroughly debride the end plates.”