The U.S. Food and Drug Administration has granted 510(K) clearance to Tissue Regeneration Systems (TRS) for its Cranial Bone Void Filler product, which is used for the repair of neurosurgical burr holes. This is the first of a family of craniomaxillofacial surgery products being developed by TRS that incorporate the company’s skeletal reconstruction and bone regeneration technology platform.
FDA Clears Regenerative Cranial Repair Product
1 min read Premium comments
Secondary
“This is a significant milestone for the company, ” said Jim Fitzsimmons, president and CEO. “To our knowledge, this is the first FDA approval of a coated bioresorbable skeletal reconstruction implant fabricated by means of 3D printing, ” he said. “This technology is definitely the wave of the future. With our base material and manufacturing processes now cleared by FDA, the approval pathway for future products can be streamlined.” TRS has filed a 510K for its second product, which is currently being reviewed by the FDA.
Using a technology developed at the Universities of Michigan and Wisconsin, TRS is developing skeletal reconstruction implants that are bioresorbable over time, completely replacing them with natural bone. Company officials say that they can bear loads and are strong enough to support function without the reinforcement of metal plates. The implants are coated with an osteoconductive coating that serves as a substrate for adhesion and the release of growth factors to enhance bone regeneration.
Founded in 2008, Tissue Regeneration Systems is a start-up medical device company with operations in Ann Arbor, Michigan and Kirkland, Washington.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.