Innovasis Receives FDA Clearance for Nano-Scale Surface Designation on AxTiHA, TxTiHA, and HAtetracell-C Implants
Engineered 20-nanometer surface architecture on Innovasis' HA-coated titanium implants was reviewed and cleared under
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Engineered 20-nanometer surface architecture on Innovasis’ HA-coated titanium implants was reviewed and cleared under the FDA’s Nanotechnology Guidance, confirming nanoscale surface features with increased hydrophilicity compared to micro-rough titanium surfaces.
SALT LAKE CITY, UT / ACCESS Newswire / September 25, 2026 / Innovasis, a privately held developer and manufacturer of spinal implant systems and surgical instrumentation, today announced that the U.S. Food and Drug Administration (FDA) has cleared the nano-scale surface technology used on its AxTiHA Stand-Alone ALIF System, TxTiHA IBF System, and HAtetracell-C Titanium Cervical IBF System implants. The nano-scale hydroxyapatite (HA) surface characterization was reviewed under the FDA’s Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, confirming the engineered nanoscale surface architecture present on these implants.
“It is with great pleasure that we can announce this clearance,” said Matt Stuttle, President and CEO of Innovasis. “This recognition reflects the partnership between Innovasis and Promimic on developing a nanoscale surface architecture for our HA-coated titanium implants, and we’re proud to receive the Nanotechnology Designation and excited to bring this cutting-edge technology to our surgeon partners and their patients.”
Nanoscale Features Confirmed in FDA 510(k) Summary
According to the public-facing FDA 510(k) Summary for the clearance, in vitro study results demonstrate that the nanoscale features of the Innovasis AxTiHA Stand-Alone ALIF System, TxTiHA IBF System and HAtetracell-C Titanium Cervical IBF System implants are “engineered and uniformly present on the implant surface and exhibit increased hydrophilicity as represented by contact angle when compared to micro-rough HA coated titanium surfaces.”
HAnano Surface Technology
True Nano-Scale Architecture
This 20-nanometer surface modification improves hydrophilicity (i.e., contact angle) compared to micro-rough HA coated titanium. *
Osteoconductive Technology
The super hydrophilic nature of HAnano Surface, in combination with its biomimicking structure and chemistry, is the foundation of its osteoconductivity. This 20-nanometer surface modification mimics natural bone mineral composition, protein adsorption, and cellular attachment.*
Higher-Quality Apposition
Studies have shown that the bone-to-implant contact was significantly improved (i.e., histology and removal torque) around implants with HAnano Surface when compared with untreated titanium controls.*
*Data on file at Innovasis. In vitro performance or animal studies may not be representative of clinical performance.
About Innovasis
Innovasis is a Salt Lake City, Utah-based designer and manufacturer of spinal implant systems and surgical instrumentation, offering a full portfolio of interbody, fixation, and biologic solutions for surgeons treating degenerative, deformity, and traumatic spine conditions.
Individual patient results may vary. Not all products are available in all markets. See the Instructions for Use for complete indications, contraindications, warnings, precautions, and potential adverse effects.
Media Contact
Innovasis
801.261.2236
Marketing@innovasis.com
www.innovasis.com
SOURCE: Innovasis
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