Material Composition | High-stress joint reconstruction surgeries | Industry Standard: Polypropylene (ISO 527 tensile strength: 25 MPa) Our Base: PEEK (ISO 10993 biocompatibility, 80 MPa) Our Advanced: Reinforced PEEK (ISO 13482, 100 MPa▲▲) | Base: Lightweight yet durable for ACL/PCL fixation. Advanced: Enhanced load-bearing capacity for complex fractures. | Base: Higher cost than polypropylene. Advanced: Requires specialized handling. |
Regulatory Classification | FDA-regulated surgical environments | Industry Standard: Class II (ISO 13485) Our Base/Advanced: Class III (ISO 13485 + FDA 21 CFR Part 880▲) | Ensures compliance with stringent medical device regulations for critical surgeries. | Higher regulatory scrutiny may delay procurement for some institutions. |
Sterilization Compatibility | Reusable/Single-use surgical kits | Industry Standard: Ethylene oxide (ETO) only Our Base: ETO + Steam Autoclave (ISO 17665-1▲) Our Advanced: ETO + Steam + Gamma Radiation (ISO 11137▲▲) | Base: Flexible sterilization options. Advanced: Radiation tolerance for bulk sterilization. | Base: Steam may degrade some plastics. Advanced: Requires specialized facilities. |
Mechanical Strength | Load-bearing joint repairs | Industry Standard: 15 Ncm insertion torque (ASTM F319) Our Base: 20 Ncm (▲) Our Advanced: 25 Ncm (▲▲) | Base: Reduces bone pullout risk. Advanced: Sustains higher post-surgery mobility demands. | Base: Limited for obese patients. Advanced: Requires precise surgical technique. |
Shelf Life | Hospital inventory management | Industry Standard: 6 months (ISO 11607) Our Base: 12 months (▲) Our Advanced: 24 months (▲▲) | Extended usability reduces stock rotation costs. | Base: Moderate storage requirements. Advanced: Requires controlled humidity. |
Biocompatibility | Implantable devices in soft tissues | Industry Standard: ISO 10993 (Cytotoxicity only) Our Base: ISO 10993 + USP Class VI (▲) Our Advanced: ISO 10993 + USP Class VI + Hemocompatibility (ISO 10993-4▲▲) | Base: Minimizes allergic reactions. Advanced: Reduces thrombosis risk in vascular proximity. | Base: Limited data for long-term implants. Advanced: Higher material costs. |