Leveraging these comprehensive advantages, PEEK artificial knee components are widely used in primary and revision total knee replacement surgeries. They are particularly suitable for patients with metal allergies, those requiring MRI examinations, or those pursuing higher levels of physical activity. They provide a reliable joint function reconstruction solution for patients suffering from degenerative knee diseases, traumatic arthritis, rheumatoid arthritis, and other conditions.

Basic Properties

Item	Parameter/Description	Test Standard	Characteristics
Core Material	Medical-grade PEEK (ISO 13485 certified)	ASTM F2026	Biocompatible / Radiolucent
Reinforced Type	CFR-PEEK (Carbon Fiber Reinforced)	—	Adjustable elastic modulus, closer to cortical bone
Color	Natural amber (inherent color)	—	Radiolucent, facilitates assessment via X-ray
Density	1.3-1.45 g/cm³ (PEEK) 1.5-1.6 g/cm³ (CFR-PEEK)	ISO 1183	Lighter than cobalt-chromium alloy (~8.5 g/cm³)
Long-term Use Temp	Can withstand short-term sterilization at 300°C	—	Stable with routine steam/radiation sterilization

Mechanical & Biomechanical Properties

Parameter	PEEK Standard Value	CFR-PEEK Value	Test Method
Elastic Modulus	3-4 GPa	15-20 GPa (Adjustable)	| ISO 527
Tensile Strength	≥90 MPa	≥200 MPa	ISO 527
Fatigue Limit (10⁷ cycles)	50-70 MPa	80-100 MPa	ISO 1099
Wear Rate (vs. UHMWPE)	≤0.05 mm³/million cycles	≤0.03 mm³/million cycles	ISO 14243
Creep Resistance (37°C/20MPa)	Deformation rate < 1%/year	Deformation rate < 0.5%/year	ISO 899-1

Biocompatibility & Clinical Performance

Performance	In Vitro Cytotoxicity	In Vivo Osseointegration	Imaging Compatibility
Standard/Result	Complies with ISO 10993-5 (Non-toxic)	Bone ingrowth rate increased by 30-50% with surface treatment	No artifacts in MRI/CT, Semi-radiolucent on X-ray
Test/Condition	L929 Cell Culture Animal Model (Sheep/Rabbit)	Animal Model (Sheep/Rabbit) 12 Weeks	1.5T/3T MRI Field Strength
Key Advantage	No metal ion release, extremely low allergy risk	Micro-porous surface or HA coating promotes osseointegration	No special imaging restrictions postoperatively

Component Specifications

Parameter	Standard Range	Special Customization
Component Type	Femoral Condyle, Tibial Tray, Patellar Component	Unicompartmental/Total Knee, Revision Systems
Size Range	Small/Medium/Large (Covers most populations)	Extra Small/Extra Large, Anatomically Matched
Fixation Method	Cemented, Press-fit, Porous-coated	Combined Fixation (Screws/Trabecular Metal Wedges/Blocks)
Surface Treatment	Smooth Articular Surface, Micro-porous Bone-contact Surface	Hydroxyapatite (HA) Coating, 3D-Printed Porous Structure

Certifications & Standards

Certification Type	Standard Number	Applicable Scope/Requirement
Medical Device Quality Management	ISO 13485	Full process of design and production
Biocompatibility	ISO 10993 Series	Comprehensive biological evaluation
US Market Access	FDA 510(k) / PMA	—
EU Medical Device Regulation	MDR (EU) 2017/745	CE Marking
China Registration	NMPA Class III Registration	High-risk implant approval

Clinical Indications Reference Table

Patient/Condition Characteristics	Recommended Component Type	Alternative/Notes
Patients with Metal Allergy History	All-PEEK or CFR-PEEK System	Zirconia Ceramic-coated Metal Components
Young, Highly Active Patients	CFR-PEEK (High Fatigue Resistance)	Highly Cross-linked Polyethylene + Cobalt-Chromium Alloy
Patients Requiring Frequent MRI Follow-up	All-PEEK System	Specific Non-magnetic Alloys (e.g., Titanium Alloy)
Osteoporosis/Poor Bone Quality	Low Modulus PEEK, with Porous Coating	Traditional Metal Stem + Cement Augmentation
Single Compartment Disease	PEEK Unicompartmental Replacement Component	Metal Unicondylar or High Tibial Osteotomy

Economic & Clinical Benefit Parameters

Type	Estimated Service Life	Revision Rate (10 Years)	Comprehensive Cost-Effectiveness Ratio
Standard PEEK Total Knee	20-25 Years	< 5%	Higher than Metal-Polyethylene Systems (Reduces Secondary Revisions)
CFR-PEEK High-Activity Type	25+ Years	< 3% (Estimated)	Higher initial cost, significant long-term benefits
PEEK Unicondylar	15-20 Years	< 8%	Preserves bone stock, easier conversion to total knee during revision

Key Notes

1.  Surgical & Implantation Points:

       Bone Bed Preparation: Requires precise matching to the bone-contact surface requirements of PEEK components to ensure initial stability.

       Fixation Choice: Cemented fixation requires ensuring uniform cement interdigitation; cementless fixation requires good bone quality and accurate press-fit.

2.  Postoperative Rehabilitation & Imaging:

       The radiolucency of PEEK requires surgeons to be familiar with its imaging appearance to avoid misinterpretation as loosening.

       Rehabilitation protocols are similar to those for metal knees, but MRI examinations for soft tissue evaluation can be performed earlier.

This product has been successfully applied in:

   Knee replacements for metal allergy patients across multiple European centers (over 1000 cases, >95% success rate at 10-year follow-up).

   High-activity knee replacements for young patients in sports medicine hospitals (CFR-PEEK components, allowing return to activities like running).

   Custom PEEK components for tumor knee reconstruction (combined with 3D printing for personalized anatomical reconstruction).