GK1028 Bone Repair Material | n-HA/PA66 Composite Bone Graft Substitute

Product Overview

GK1028 Bone Repair Material is a high-performance composite bone graft substitute composed of medical nano-hydroxyapatite/polyamide 66 (n-HA/PA66). Designed based on bionic principles, it mimics the composition and mechanical properties of natural bone, providing effective support and repair for bone defects in clinical scenarios. It is widely used in orthopedic, spinal, and joint surgeries to address bone defects caused by trauma, degeneration, or surgical resection, becoming a reliable choice for bone tissue repair.

Core Material & Bionic Principle

The product adopts a component bionic design that highly simulates the composition of natural autologous bone, ensuring excellent biological compatibility and bioactivity:

Component Bionics	Inorganic Component	Organic Component
Autologous Bone	Nano-hydroxyapatite	Type I Bone Collagen
GK1028 (n-HA/PA66)	Nano-hydroxyapatite	Polyamide 66

This bionic component structure enables the material to integrate with host bone tissue more effectively, laying a foundation for stable bone regeneration.

Mechanical Performance Advantages

GK1028's mechanical properties are closely matched to natural cortical bone, effectively avoiding the "stress shielding effect" (a common issue with traditional bone graft materials):

Material	Compressive Strength (MPa)	Elastic Modulus (GPa)
GK1028 (n-HA/PA66)	100–130	3–30
Cortical Bone	80–120	3–20

The matched mechanical performance provides reliable early support for the defect site while adapting to the stress changes of the host bone during healing, promoting better bone integration.

Core Product Advantages

Authoritative Clinical Recognition

Ranked first in the national volume-based procurement (Group A), meeting the strict quality and efficacy standards of clinical procurement, and widely recognized by medical institutions.

Multi-Scenario Clinical Adaptability

Suitable for bone repair and filling in trauma, spinal, and joint scenarios, covering common clinical bone defect needs (e.g., fracture defect repair, spinal fusion bone grafting, joint reconstruction bone supplementation).

Reliable Early Mechanical Support

Mechanical properties closely match cortical bone, providing stable support for the defect site immediately after implantation, avoiding collapse or displacement of the repair area.

Excellent Biological Compatibility

The bionic component design ensures good biocompatibility, promoting tight interface osteogenesis between the material and host bone, and enhancing the stability of the repair effect.

Long-Term Clinical Safety Verification

With 20 years of clinical application history, the product has been proven safe and effective in a large number of clinical cases, with a low incidence of adverse reactions.

Clinical Application Scenarios

Trauma Application

Used for the repair of bone defects caused by fractures (e.g., long bone fracture defects, articular process fracture defects), providing support for fracture healing.

Spinal Application

Applied in spinal fusion surgeries (e.g., interbody fusion, posterior lateral fusion), filling the fusion area to promote spinal stability and bone fusion.

Joint Application

Used for bone defect repair in joint surgeries (e.g., hip/knee joint replacement bone supplementation, articular surface defect repair), helping to restore joint structure and function.

Safety & Compliance

Regulatory Certification: Certified with National Medical Device Registration Certificate (Registration No.: Guoxie Zhunzi 20183131720), complying with national medical device safety and efficacy standards.
Biological Safety: Passed biocompatibility testing, with no toxic, sensitizing, or irritating reactions to human tissue.
Long-Term Clinical Data: Verified by 20 years of clinical application, with a high success rate of bone repair and good long-term prognosis.

Frequently Asked Questions (Q&A)

Q1: What types of bone defects is GK1028 suitable for?

A1: It is suitable for various bone defects in orthopedic, spinal, and joint scenarios, including fracture-related bone defects, spinal fusion bone grafting, and joint surgery bone supplementation. It is not recommended for defects with severe infection or poor soft tissue coverage (to be evaluated by clinicians).

Q2: How does GK1028 solve the "stress shielding effect"?

A2: Its mechanical properties (compressive strength, elastic modulus) are closely matched to natural cortical bone. This avoids excessive stress concentration on the material (or implants) and insufficient stress on the host bone, thus reducing the risk of bone resorption or implant loosening caused by stress shielding.

Q3: How long does it take for GK1028 to integrate with host bone?

A3: The integration process varies by individual and defect location: generally, initial interface osteogenesis can be observed 4–8 weeks after implantation, and complete bone integration (with material degradation and new bone formation) takes 6–12 months. Specific progress needs to be evaluated by clinical imaging (e.g., X-ray, CT).

Q4: Is GK1028 a resorbable material?

A4: It has a certain degradation property: the material gradually degrades as new bone forms, and the degradation rate matches the speed of new bone growth, eventually being replaced by host bone tissue. The complete degradation cycle is usually 12–24 months.

Q5: Has GK1028 been widely used in clinical practice?

A5: Yes. It has 20 years of clinical application history, and its safety and efficacy have been verified by a large number of clinical cases. It has also won the first place in national volume-based procurement (Group A), indicating high recognition in the medical industry.

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