SIGNAFUSE® Bioactive Synthetic Bone Graft (Putty & Strip Formats)

Product Overview & Description

SIGNAFUSE® Bioactive Synthetic Bone Graft is an advanced, 100% synthetic osteoconductive scaffold engineered to activate bone-forming cells and signal fusion in orthopedic and spinal surgical procedures. SIGNAFUSE combines a synergistic blend of bioactive glass with a biphasic mineral matrix composed of 60% Hydroxyapatite (HA) and 40% Beta-Tricalcium Phosphate ($\beta$-TCP)—a ratio clinically proven to deliver predictable resorbability and safe bone formation.

Available in both moldable Putty (pre-filled syringe applicator) and flexible Strip formats, SIGNAFUSE provides superior intraoperative handling and structural stability. The bioactive glass component reacts rapidly in vivo to release essential ions that accelerate cellular activity, induce high levels of osteoblast differentiation, and kickstart natural osteogenesis without requiring human or animal donor tissue.

About This Item

• Bioactive Synergistic Matrix: Blends bioactive glass with a 60:40 HA/$\beta$-TCP biphasic mineral scaffold to accelerate osteoblast differentiation and signal bone fusion.

• Clinically Proven Mineral Ratio: Utilizes a 60% Hydroxyapatite and 40% $\beta$-Tricalcium Phosphate ratio supported by multiple prospective and randomized controlled surgical trials.

• Dual Formats (Putty & Strip): Available in moldable putty (pre-loaded in ergonomic syringe applicators) and flexible, conformable strip matrices to fit diverse anatomical defects.

• Exceptional Intraoperative Handling: Handles like a dream—resists irrigation wash-out, molds easily into surgical voids, and maintains structural integrity throughout graft placement.

• 100% Synthetic & HTA-Exempt: Completely synthetic biocomposite containing zero human cell or donor tissue materials, requiring no HTA Establishment Licence for distribution.

Indications & Usage

• Primary Indication: Indicated for use as a synthetic bone graft extender or bone void filler for osseous defects in the skeletal system (e.g., spine, pelvis, and extremities) that are not intrinsic to the stability of the bony structure.

• Administration: Prepared and placed directly into bony voids or combined with autologous blood, bone marrow aspirate (BMA), or autograft bone by a qualified surgeon in an operating room setting.

Summary of Safety & Precautions

• Contraindications: Do not use in patients with severe vascular impairment at the implant site, active systemic infection, or localized infection at the surgical site. Not intended to provide primary mechanical support in load-bearing applications.

• Precautions: Ensure complete void packing without excessive pressure. Designed strictly for single-patient, single-procedure surgical use.

Product Specifications

• Brand Name: SIGNAFUSE®

• Manufacturer: Bioventus LLC

• Material Composition: Bioactive Glass + Biphasic Mineral (60% Hydroxyapatite / 40% $\beta$-TCP)

• Formats Available: Pre-filled Syringe Putty & Moldable Flexible Strips

• Regulatory Notice: This product is strictly classed as a medical device (not a medicine).