AMS Spring 2023

FDA (510)k Clearance Awarded to 3D Printed Medical Implants from Camber Spine Technologies and Renovis Surgical Technologies

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Following in the recent footsteps of SI-BONE’s iFuse-3D Implant and Cellular Titanium spinal implants by EIT, two more medical device companies have announced this week that they have received the all-important (510)k clearance from the US Food and Drug Administration (FDA) for 3D printed titanium spinal implants. This stamp of approval is increasingly important, especially as 3D printers and medical regulations come further under the microscope.

First up is Camber Spine Technologies, located in Pennsylvania and dedicated to exploring the next level of implant design by creating minimally invasive access solutions that are designed by surgeons to treat spinal issues.

The company has announced that its SPIRA Open Matrix ALIF device has received 510(k) clearance, and will soon have a national launch. SPIRA is an interbody fusion implant, designed to increase stabilization and fusion rates. It is made of spiral support arches, which maximize bone graft capacity and decrease subsidence by sharing the load over the implant’s entire endplate, and Camber’s Surface by Design Technology, which is a roughened surface that can facilitate bone growth by using a trabecular pattern, optimized pore diameter, and strut thickness.

The Camber Spine SPIRA Open Matrix ALIF was designed specifically to help patients maintain their sagittal balance, while also maximizing graft volume and reducing subsidence. The device includes both anterior and anterolateral insertion options, with heights ranging, in 2 mm increments, from 9 to 19 mm. The 3D printed solution, which is a first for Camber’s spinal implants, is indicated that it is for use in skeletally mature patients who suffer from Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.

“Camber Spine is very excited to be launching our first in a series of spinal implants using 3D printed – additive manufacturing. This specialized manufacturing technology allows us to create these truly unique patented structures featuring open arched matrices and proprietary surfaces designed to enhance fusion and promote bone growth. In the coming months we will be launching a series of five SPIRA spinal interbody cages for cervical, lateral, and posterior lumbar spine. Extremity implants and custom implants for salvage and complex deformity implants are also under development,” said Camber Spine CEO Daniel Pontecorvo.

“We believe that the addition of SPIRA and ENZA MIS Integrated interbody devices to our product portfolio create a foundation of patented implant solutions that will drive the growth of  Camber Spine.”

The SPIRA device, which is the tenth line of spinal implant systems that the company has released in the US, should only be used with additional FDA-cleared supplementary fixation systems.

Headquartered in California, Renovis Surgical Technologies has also received FDA clearance for its latest 3D printed device. The company was founded in 2009, with a goal of creating high quality implants for trauma, spine, and orthopedics. Renovis will now be able to bring its posterior lumbar Tesera porous titanium interbody fusion systems, which have implants for both transforaminal (TLIF) and direct posterior (PLIF) approaches in curved and straight options, to the US market.

The Tesera implants come in different heights, lengths, and widths to offer a good fit for different patient anatomies, and the company combines 3D printing with its proprietary Tesera Trabecular Technology, a highly porous structure, to make the implants.

SEM image of the outer surface of the Tesera porous structure

The structure helps bones attach to the implant surfaces and has “the potential for biologic fixation deep into the pore structure for long-term stability,” as the company explained in the announcement. With this latest approval, Renovis Surgical Technologies has now succeeded in gaining FDA clearance for a total of five product groups that feature its Tesera porous titanium structure. Discuss in the FDA forum at 3DPB.com.

[Images: Camber Spine Technologies, Renovis Surgical Technologies]

 

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