FDA (510)k Clearance Awarded to 3D Printed Medical Implants from Camber Spine Technologies and Renovis Surgical Technologies
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]
Subscribe to Our Email Newsletter
Stay up-to-date on all the latest news from the 3D printing industry and receive information and offers from third party vendors.
Print Services
Upload your 3D Models and get them printed quickly and efficiently.
You May Also Like
Ricoh USA Sells 3D for Healthcare Spinout to Former VP and GM, Rebrands as Myrava
Japanese companies are really good at internal diversification and spin-outs, and this seems to be true even in cases involving foreign subsidiaries of Japanese multinationals. Ricoh USA recently demonstrated this...
Phase3D Puts Its ISM Hardware in the Hands of AM’s Future Workforce with DEHub Partnership
The US additive manufacturing (AM) industry faces a turning point in terms of its approach to R&D. As has been the case for aggregate R&D in the US economy at...
Walter Reed Gets Premarket Clearance to Make 3D Printed Point-of-Care Medical Devices
The Walter Reed National Military Medical Center’s 3-D Medical Application Center (3-D MAC) has received premarket clearance to make 3D printed medical devices. This is the first time that a...
Electroninks’ EMI Shielding Materials Give it an Expanded Presence in Japan
In the current global economic context, which is being shaped primarily by national leaders trying out new forms of geopolitical leverage on a daily basis, advanced manufacturing partnerships between American...
