Tissue Regeneration Systems won FDA clearance for its 3D-printed Cranial Bone Void Filler, the flagship product in a suite of devices indicated for cranial reconstruction.
Designed to fill holes left behind after surgery, the CBV filler appears to be the 1st 3D-printed device of its kind to get the FDA’s green light for the U.S. market.
The CBV filler is the 1st in a family of craniomaxillofacial surgery products that incorporate the TRS’s novel skeletal reconstruction and bone regeneration technology platform, the start-up medical device company with operations in Ann Arbor, Michigan and Kirkland, Washington said in a press release.
"To our knowledge, this is the first FDA approval of a coated bioresorbable skeletal reconstruction implant fabricated by means of 3D printing," TRS president & CEO Jim Fitzsimmons said in prepared remarks. "This technology is definitely the wave of the future."
TRS’ developmental line of advanced skeletal reconstruction implants apply a technology platform created at the Universities of Michigan and Wisconsin. They are bioresorbable over time as the voids heal with natural bone, according to the company.
The implants are designed to be porous in order facilitate bone healing, but they can take a heavy load without the need for metal plating as reinforcement, which means they can be used as an alternative to bone harvested from the patient for complex skeletal reconstruction, TRS noted. The implants can also be customized to fit a patient’s anatomy and void geometry.
"This is a significant milestone for the company," Fitzsimmons said. "With our base material and manufacturing processes now cleared by FDA, the approval pathway for future products can be streamlined."
TRS has already filed a 510(k) application for a 2nd product which is currently being reviewed by FDA. The company is also working on other submissions, Fitzsimmons added.