Advanced Pre-Sterilized Orthopedic Implants Overview
Orthi Medical Co., Ltd. supplies premium, ready-to-use pre-sterilized orthopedic implants engineered for immediate surgical application. By shifting the sterilization process from hospital operating rooms to our ISO 13485 certified cleanroom manufacturing facilities, we deliver verified sterility, eliminate reprocessing costs, and significantly reduce clinical infection risks for global healthcare providers and medical distributors.
Co-60 Gamma Sterilization
Sterilized via Cobalt-60 gamma ray irradiation reaching a validated Sterility Assurance Level (SAL) of 10⁻⁶ in accordance with ISO 11137 standards.
ASTM Standard Titanium
Manufactured from premium pure titanium (ASTM F67 TA2/TA3) and high-strength titanium alloy Ti-6Al-4V (ASTM F1472 TC4) with tensile strength ≥930 MPa.
Full Batch Traceability
Individual double-pouch Tyvek packaging with UDI barcodes, chemical indicator dots, and batch lot numbers for seamless hospital inventory tracking.
Implant Material Standards & Mechanical Properties
Every raw material batch undergoes rigid spectroscopic and mechanical testing before machining. Orthi Medical Co., Ltd. strictly controls chemical composition limits to maximize biocompatibility, corrosion resistance, and fatigue endurance in trauma fixation procedures.
Chemical Composition of Implant Titanium
| Element Limit (%) |
Pure Titanium (TA2) |
Pure Titanium (TA3) |
Ti-6Al-4V Alloy (TC4) |
Compliance Standard |
| Nitrogen (N) Max. |
0.03% |
0.05% |
0.05% |
ASTM F67 / F1472 |
| Carbon (C) Max. |
0.08% |
0.08% |
0.08% |
ASTM F67 / F1472 |
| Hydrogen (H) Max. |
0.008% |
0.008% |
0.008% |
ASTM F67 / F1472 |
| Iron (Fe) Max. |
0.30% |
0.30% |
0.30% |
ASTM F67 / F1472 |
| Oxygen (O) Max. |
0.25% |
0.35% |
0.20% |
ASTM F67 / F1472 |
| Aluminum (Al) |
- |
- |
5.50% - 6.75% |
ASTM F1472 |
| Vanadium (V) |
- |
- |
3.50% - 4.50% |
ASTM F1472 |
Mechanical Performance Metrics
| Material Grade |
Tensile Strength (Rm) |
Yield Strength (Rp0.2) |
Elongation After Break (A) |
Typical Clinical Application |
| Pure Titanium TA2 |
≥ 400 MPa |
≥ 275 MPa |
≥ 20% |
Craniofacial, Mini plates, Soft tissue anchors |
| Pure Titanium TA3 |
≥ 500 MPa |
≥ 380 MPa |
≥ 12% |
Small bone locking plates, Reconstructive meshes |
| Titanium Alloy TC4 (Ti-6Al-4V) |
≥ 930 MPa |
≥ 860 MPa |
≥ 10% |
Large trauma locking plates, Intramedullary nails, Compression screws |
Sterile Product Lines & Sourcing Specifications
Our pre-sterilized package program includes a comprehensive selection of trauma systems available for global distributor orders. Each item is pre-packed in protective blister trays and Tyvek pouches, ready for instant surgical deployment.
| System Family |
Product Description |
Size & Specification Options |
Material Grade |
Sterilization Method |
| CanMFP (Mini Fragment) |
2.0mm LCP T-Plate, L-Plate, Y-Plate & Condylar Plates |
2 to 12 Holes (Left / Right options) |
Pure Titanium / TC4 |
Co-60 γ-Ray (SAL 10⁻⁶) |
| CanSLP (Small Fragment) |
3.5mm LCP T-Plates, Reconstruction Plates & Clavicle Hook Plates |
3 to 22 Holes (Straight & Curved) |
Titanium TC4 (ASTM F1472) |
Co-60 γ-Ray (SAL 10⁻⁶) |
| CanLLP (Large Fragment) |
4.5mm Broad LCP Plates & Proximal Femoral Locking Plates |
4 to 18 Holes |
Titanium TC4 (ASTM F1472) |
Co-60 γ-Ray (SAL 10⁻⁶) |
| CanCCS (Cannulated Screws) |
Headless Compression Screws & Cannulated Screws |
Ø2.5 / Ø3.0 / Ø4.0 / Ø4.5 / Ø5.0 / Ø6.5 mm (Lengths 8-120mm) |
Titanium TC4 (ASTM F1472) |
Co-60 γ-Ray (SAL 10⁻⁶) |
| CanSFP (Cortex Screws) |
Self-Tapping Cortex & Cancellous Bone Screws |
Ø1.5 / Ø2.0 / Ø2.4 / Ø2.7 / Ø3.5 / Ø4.5 / Ø5.0 / Ø6.5 mm |
Titanium TC4 (ASTM F1472) |
Co-60 γ-Ray (SAL 10⁻⁶) |
| CanETN / CanEFN |
Expert Tibia & Femoral Intramedullary Nails |
Ø8 - Ø13 mm (Lengths 255 - 420 mm) |
Titanium TC4 (ASTM F1472) |
Co-60 γ-Ray (SAL 10⁻⁶) |
Frequently Asked Questions for Sourcing Partners
How does Orthi Medical ensure the sterility of pre-packaged implants?
Every sterile implant manufactured by Orthi Medical Co., Ltd. undergoes Cobalt-60 (γ-ray) radiation sterilization inside validated medical-grade packaging. We strictly adhere to ISO 11137 standards, guaranteeing a Sterility Assurance Level (SAL) of 10⁻⁶, with biological and chemical indicators verified for every batch.
What packaging materials are used for long-term shelf life?
Implants are secured within rigid PETG blister trays and sealed in breathable DuPont Tyvek double-layer pouches. This packaging provides robust physical protection, maintains sterile barrier integrity, and supports a shelf life of up to 5 years.
Does Orthi Medical support OEM private labeling for sterile products?
Yes. We provide complete OEM/ODM solutions for international brands, including custom laser marking on implants, custom-branded Tyvek pouch printing, outer box packaging design, and comprehensive technical files to support local regulatory registration.
What documentation accompanies sterile implant shipments?
Each shipment is supplied with Certificates of Analysis (CoA), raw material mill certificates (ASTM F67/F1472 compliance), gamma sterilization validation reports, and complete lot traceability records.