Artidyz Bioceramic Bone Graft

AUSK Cementless Unicompartmental Knee System

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Artidyz™ Bioceramic Bone Graft

The product is similar to the inorganic composition of natural bone and consists of 85% β-Tricalcium Phosphate (β-TCP) and 15% Hydroxyapatite (HA), forming a biphasic porous bioceramic bone graft.

Hydroxyapatite closely resembles the inorganic component of natural bone and provides high strength and excellent biocompatibility; however, pure HA is brittle, has low toughness, insufficient fatigue resistance in physiological environments, and degrades slowly.

β-TCP demonstrates good biocompatibility and bioactivity, but its degradation rate is too fast to match the growth rate of new bone.

The combination of HA and β-TCP into biphasic calcium phosphate creates a synergistic effect, providing enhanced bioactivity and an appropriate degradation rate to promote new bone formation.

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Excellent Biocompatibility

Similar to the inorganic composition of natural bone, providing high strength and excellent biocompatibility.

High biocompatibility

Bioceramic materials (HA, β-TCP) closely resemble the mineral composition of human bone and do not trigger immune or rejection responses.

Promotes osteoblast adhesion and proliferation

Provides a favorable environment for osteoblast and mesenchymal stem cell adhesion, proliferation, and differentiation, promoting new bone formation.

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Controlled Biodegradability

A unique formulation enables gradient degradation of β-TCP and HA, supporting osteogenesis.

Material degradation occurs simultaneously with new bone formation in vivo.

Degradation releases Ca and P ions, increasing the local ionic concentration, promoting HA precipitation and epitaxial growth, enhancing osteogenesis and bone defect repair.

※ During the observation period, the mass loss rates of the experimental group, control group 1, and control group 2 were similar

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Excellent Bone Filling Capability

Porous structure promotes bone ingrowth

● 300–800 μm macropore size

● 60% total porosity

● 10% microporosity

Interconnected pores allow vascularization and fluid penetration, supporting cell migration, proliferation, and differentiation.

SEM images show interconnected macropores (300–800 μm) in the test group, while the control group shows pores <100 μm without interconnectivity.

Pores >100 μm support endochondral ossification, and >300 μm support direct bone formation.

Microporosity enhances protein adsorption, a prerequisite for cell adhesion and differentiation.

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Animal Study

HE stained histopathology microscope image (6X)

A 26-week bone implantation study evaluated 12 implantation sites. All sites were included in the analysis. Abundant new bone formation was observed at the pore openings, with close bonding between the coating and newly formed bone. No fibrous capsule formation or inflammatory cells were observed.

Results

Artidyz™ Bioceramic Bone Graft 3

1. The response was classified as non-irritant or extremely mild irritation. At the study endpoint, neither the implant sites nor the surrounding tissues in the test or control groups showed any obvious necrosis, and only minimal

local tissue reaction was observed.

2. Under HE staining, newly formed trabecular bone was observed around the implantation site. Thick collagen fibers were arranged in a well-organized lattice structure. Bone lacunae were small and contained mature osteocytes.

Osteoblasts were arranged in rows along the periphery, with a small number of osteoclasts also present.

Instructions for Use

After exposing the defect, remove necrotic and soft tissues from the bone defect site.

Irrigate the defect site with sterile saline and remove excess fluid to ensure adequate blood supply at the graft site.

Place the bioceramic bone graft granules into the defect site, ensuring close contact with the surrounding bone walls. Avoid excessive force to prevent particle fragmentation.

After placement of the bioceramic bone graft granules, close the surgical site using standard closure techniques.

Models & Specifications

Type	Model & Specification	Parameter
Type	Model & Specification	Particle Size (mm)	Net Weight (g)	Volume (cm³)
Granules	Bc-d1-m1	0.2~1.0	1	1.2
	Bc-d1-m2		2	2.5
	Bc-d1-m5		5	6.2
	Bc-d2.8-m1	1.0~2.8	1	2.0
	Bc-d2.8-m2		2	4.0
	Bc-d2.8-m5		5	10.0
	Bc-d5.6-m1	2.8~5.6	1	2.1
	Bc-d5.6-m2		2	4.2
	Bc-d5.6-m5		5	10.4