XC Medico
Clinical Academy

All XC Medico metallic implants (Titanium Ti-6Al-4V and 316L Stainless Steel) are compatible with steam autoclave sterilization at 134°C / 273°F for a minimum of 18 minutes (pre-vacuum cycle). For PEEK interbody cages, use 134°C for 4 minutes pre-vacuum. Instrument trays should be wrapped in single-use pouches. EtO (ethylene oxide) sterilization at ≤55°C is also approved for heat-sensitive components. Do not use chemical/cold sterilization liquids as these may compromise surface coatings. Full IFU (Instructions for Use) detailing sterilization protocols is included in every product packaging.

XC Medico uses Ti-6Al-4V ELI (Extra-Low Interstitial) Grade 23 per ASTM F136, the medical-grade standard. Key properties: Tensile strength ≥860 MPa, yield strength ≥795 MPa, elongation ≥10%. The alloy composition is 90% Titanium, 6% Aluminum, 4% Vanadium. Bone plates and screws undergo a Type II anodization surface treatment to enhance corrosion resistance and osseointegration. This alloy is MRI-conditional at 1.5T and 3T with specific scan conditions detailed in the product labeling.

All Titanium-based XC Medico implants are classified as MR Conditional per ASTM F2503. They are safe at 1.5T and 3.0T field strength with a maximum spatial gradient of 720 G/cm. Stainless steel implants (316L) are also MR Conditional but may cause larger image artifacts; coordinate with the radiologist. Do not perform MRI within 6 weeks of implantation unless clinically urgent. Specific SAR (Specific Absorption Rate) limits and positioning restrictions are provided in the individual product IFU documents available in the Resource Center above.

Recommended final tightening torques vary by screw diameter: 3.5mm cortical screws: 1.2–1.5 Nm, 4.5mm cortical screws: 2.0–2.5 Nm, 5.0mm locking screws: 2.8–3.2 Nm, 6.5mm cancellous screws: 3.5–4.0 Nm. Always use a calibrated torque-limiting screwdriver and never exceed the maximum torque to avoid stripping the locking mechanism or cold-welding. If manual resistance is felt during insertion before reaching final depth, stop and verify drill hole diameter with the correct drill guide sleeve. Stripped locking screws require a specialized removal kit available separately.

XC Medico implants in intact sterile packaging have a shelf life of 5 years from the manufacturing date (see label). Storage conditions: temperature +5°C to +30°C, relative humidity 15–85% non-condensing, away from direct sunlight and corrosive chemicals. Any packaging showing punctures, moisture, or compression damage must be quarantined and not used. PEEK and resorbable components may have shorter shelf lives (typically 3 years) — always check the individual product label. Traceability records (lot number, expiry, patient use) must be maintained per local MDR regulations.

XC Medico holds the following certifications: ISO 13485:2016 (Quality Management System), CE Marking under EU MDR 2017/745 (Class IIb), and CFDA / NMPA registration for the Chinese market. Products destined for specific markets may carry additional local approvals — consult your regional sales contact. OEM partners may request audit reports and Declaration of Conformity documents from our Regulatory Affairs team. We do not currently hold FDA 510(k) clearance for the US market; please confirm market eligibility before placing orders for US-bound inventory.