PFNA System
PFNA Antirotation Nail
Features a single helical blade that compacts cancellous bone. 125°, 130°, 135° CCD angles, lengths 180–420 mm.
ASTM F1472Ti-6Al-4V Medical Grade
5° M-L AngleAnatomical Trochanteric Entry
SAL 10-6Gamma Sterile Packaging
ISO 13485Full OEM & Regulatory Support
Biomechanical Superiority
Engineering Excellence in Trochanteric & Subtrochanteric Fixation
Trochanteric femoral fractures (AO/OTA 31-A1, A2, and A3) present complex biomechanical challenges, particularly in geriatric populations suffering from poor cancellous bone density and osteoporotic degeneration. As an experienced orthopedic device manufacturer, Orthi Medical Co., Ltd. has developed the Proximal Femoral Nail (PFN) and Proximal Femoral Nail Antirotation (PFNA) systems to achieve superior rotational stability, prevent cut-out, and accelerate post-operative load bearing.
Our Proximal Femoral Nail implants integrate an anatomical 5° medio-lateral angle that simplifies insertion through the tip of the greater trochanter. By combining dynamic telescopic compression with controlled anti-rotation mechanisms, Orthi Medical Co., Ltd. supplies medical device distributors and hospital networks worldwide with surgical systems designed to minimize perioperative complications and revision surgeries.
- Optimized Cut-Out Resistance: Helical blade options compact bone around the blade thread, increasing pull-out resistance in osteoporotic femoral heads.
- Dynamic & Static Locking: Dual distal locking options allow surgeons to select controlled axial dynamic collapse or rigid static fixation based on fracture morphology.
- High-Precision Instrument Kits: Carbon-fiber radiolucent aiming arms provide pinpoint distal and proximal targeting under fluoroscopy.
Product Portfolio
Proximal Femoral Nail Implants & Surgical Instrumentation
Explore Orthi Medical Co., Ltd.'s comprehensive line of trochanteric nails, lag screws, helical blades, and targeted delivery sets.
Fixation Screws
Cannulated Lag & Hip Screws
Ø10.5 mm lag screws and Ø6.5 mm antirotation neck screws designed for dual-screw PFN configurations.
Long PFN
Long Trochanteric Nail
Anatomically curved (R1.5m curvature) for extended subtrochanteric fractures, featuring multi-planar distal locking.
Instrumentation
Radiolucent PFN Instrument Tray
Carbon-fiber targeted guides, tissue-protecting sleeves, depth gauges, and reamers for minimally invasive insertion.
| System Parameter | Standard PFN System | PFNA (Helical Blade) System | Long Subtrochanteric PFN |
|---|---|---|---|
| Indication | Pertrochanteric & Intertrochanteric (31-A1/A2) | Osteoporotic Trochanteric Fractures (31-A1/A2/A3) | Subtrochanteric & Combined Shaft Fractures |
| Material | Ti-6Al-4V ELI (ASTM F1472) | Ti-6Al-4V ELI (ASTM F1472) | Ti-6Al-4V ELI (ASTM F1472) |
| Proximal Diameter | 16.0 mm / 17.0 mm | 16.5 mm | 16.5 mm |
| Distal Diameters | Ø9.0, Ø10.0, Ø11.0, Ø12.0 mm | Ø9.0, Ø10.0, Ø11.0, Ø12.0 mm | Ø9.0, Ø10.0, Ø11.0, Ø12.0 mm |
| CCD Angles | 125°, 130°, 135° | 125°, 130°, 135° | 125°, 130° |
| Length Options | 180 mm, 240 mm | 170 mm, 200 mm, 240 mm | 300 mm – 420 mm (20 mm increments) |
| Fixation Element | Lag Screw (Ø10.5 mm) + Neck Screw (Ø6.5 mm) | Helical Antirotation Blade (Ø10.5 mm) | Helical Blade or Dual Screw Option |
| Distal Locking | Static & Dynamic Slot | Static & Dynamic Slot | Multi-planar (Transverse + Oblique) |
Market Intelligence
Future Procurement & Innovation Trends in Proximal Femoral Nailing
Insight for medical device sourcing leaders, procurement directors, and hospital supply chain managers evaluating the next decade of trauma care.
1. Helical Blade Domination over Traditional Lag Screws
Global procurement data reveals an accelerating shift from traditional dual lag screw PFN implants toward single helical blade PFNA designs. Helical blades achieve superior mechanical anchorage by radially compacting trabecular bone rather than reaming it out, reducing cut-out rates in osteoporotic bone by up to 68%.
2. Demand for Pre-Sterile Single-Use Packaging Kits
Hospital networks increasingly require gamma-irradiated pre-sterilized implant packaging (SAL 10-6). Pre-sterilized PFN systems lower sterilization costs for healthcare facilities, eliminate cross-contamination risks, and provide complete barcode traceability from factory cleanroom to operating room.
3. Carbon-Fiber Radiolucent Aiming & MIS Protocols
Surgeons demand ultra-lightweight, radiolucent aiming arms made from carbon-fiber reinforced polyetheretherketone (PEEK). Clear fluoroscopic visualization reduces radiation exposure for surgical staff while facilitating sub-millimeter precision when locking distal screws dynamically.
4. Anatomical Optimization for Regional Morphologies
Modern PFN designs move away from one-size-fits-all curvature. Sourcing trends prioritize manufacturers capable of supplying localized anterior radius of curvature (e.g., R1.5m vs. R1.8m) to avoid anterior cortical impingement in patient populations with smaller femoral anatomy.
Enterprise Capabilities
Why Global Brands Partner with Orthi Medical Co., Ltd. for PFN Manufacturing
Orthi Medical Co., Ltd. operates state-of-the-art 5-axis CNC machining centers, high-precision Swiss lathes, and automated surface treatment lines. We provide comprehensive OEM/ODM manufacturing services, helping orthopedic distributors launch private-label Proximal Femoral Nail lines with verified compliance and predictable lead times.
ISO 13485QMS Certified
ISO 9001Quality Assured
CE MarkedEU Compliant
| Property | ASTM F1472 (Ti-6Al-4V) | Orthi Medical Standard |
|---|---|---|
| Tensile Strength (MPa) | ≥ 930 MPa | Verified ≥ 960 MPa |
| Yield Strength (MPa) | ≥ 860 MPa | Verified ≥ 890 MPa |
| Elongation (%) | ≥ 10% | Verified ≥ 12% |
| Fatigue Endurance limit | ISO 7206-4 / ASTM F384 | 5 Million Cycles Pass |
Custom OEM Engineering
Streamlined OEM/ODM Process for Proximal Femoral Nail Systems
From technical drawing review to regulatory dossier preparation, Orthi Medical Co., Ltd. provides a seamless four-step contract manufacturing model:
1
CAD Design & Finite Element Analysis (FEA)
Our bio-engineers refine nail geometry, stress points, and locking hole positions based on customer specifications or reference samples.
2
Rapid Prototyping & Mechanical Verification
High-precision CNC prototyping, followed by fatigue, torsion, and pull-out testing according to ASTM F384 and ISO 12189 standards.
3
Automated Production & Anodization
Multi-axis Swiss lathe turning, laser marking of lot numbers, and Type II titanium anodization for enhanced surface wear resistance.
4
Sterile Packaging & Registration Files
Cleanroom packaging in ISO Class 7 facilities, Co-60 gamma sterilization, and complete STED/MDD/MDR technical documentation support.
Academic & Clinical Support
Empowering Surgeons with Comprehensive PFN Training
Orthi Medical Co., Ltd. supports global distributors with academic resources, surgeon workshops, and detailed technique manuals to ensure optimal clinical outcomes.
Surgical Technique Guides
Step-by-step documentation detailing entry point location, reaming, blade insertion, and distal locking techniques.
Cadaver & Sawbones Workshops
Hands-on training modules for distributor sales representatives and orthopedic surgeons.
Case-Based Technical Consultations
Engineering assistance for complex subtrochanteric fracture configurations and custom hardware requests.
International Academic Conferences
Active participation in global orthopedic conventions to present clinical outcome studies on PFN fixation.
Clinical Feedback
Trusted by Trauma Specialists Globally
"The PFNA Helical Blade system from Orthi Medical Co., Ltd. offers exceptional tactile feedback during insertion into osteoporotic bone. The precision of their radiolucent aiming arm drastically cuts operative time and fluoroscopic exposure."
"Orthi Medical Co., Ltd. has provided OEM Proximal Femoral Nails for our regional brand for over five years. Their strict adherence to ISO 13485 and ASTM F1472 material standards makes registration effortless in our market."
Buyer's Procurement Guide
Proximal Femoral Nail Procurement FAQs
Key questions answered regarding mechanical specifications, OEM customization, regulatory files, and global supply logistics for Proximal Femoral Nail systems.
Get a QuoteWhat is the difference between a Helical Blade and a Lag Screw in Proximal Femoral Nailing?
A helical blade compacts cancellous bone around the implant upon insertion, significantly enhancing fixation strength and reducing cut-out rates in osteoporotic bone. In contrast, standard lag screws remove bone during insertion. Orthi Medical Co., Ltd. provides both PFNA helical blade configurations and traditional dual lag screw options to suit surgeon preference and patient bone quality.
How does Orthi Medical Co., Ltd. ensure low cut-out rates and optimal Tip-Apex Distance (TAD)?
Orthi Medical Co., Ltd. manufactures Proximal Femoral Nails with precise anatomical angles (125°, 130°, 135°) and offers targeted radiolucent aiming instrumentation. This enables surgeons to position the helical blade or lag screw accurately in the lower half of the femoral head with a Tip-Apex Distance (TAD) under 20 mm, minimizing mechanical failure risks.
What titanium material grades are used in Orthi Medical Proximal Femoral Nails?
All Orthi Medical Proximal Femoral Nails are fabricated from medical-grade Titanium Alloy Ti-6Al-4V ELI conforming to ASTM F1472 / ISO 5832-3 standards. This material delivers superior tensile strength (≥930 MPa), excellent fatigue resistance, and biocompatibility superior to standard stainless steel.
Can Orthi Medical Co., Ltd. provide custom OEM/ODM Proximal Femoral Nail systems with private labeling?
Yes. Orthi Medical Co., Ltd. specializes in OEM/ODM manufacturing. We offer custom nail geometry, tailored distal locking patterns, private label laser marking, customized instrument trays, and registration documentation for global healthcare brands.
Are Orthi Medical Proximal Femoral Nails available in pre-sterilized packaging?
Yes. In addition to non-sterile bulk packaging, Orthi Medical Co., Ltd. supplies individually pouch-sealed, Co-60 gamma-sterilized Proximal Femoral Nails certified to a Sterility Assurance Level of SAL 10-6, ready for direct operating room deployment.
What technical dossier and compliance documentation are provided for market registration?
We supply comprehensive CE and ISO 13485 technical documentation, including raw material certificates (MTR), dynamic fatigue test reports per ASTM F384, biocompatibility assessments, sterilization validation reports, and surgical technique manuals.
How does the 5-degree anatomical M-L angle aid in trochanteric insertion?
The 5° medio-lateral angle allows insertion directly at the tip of the greater trochanter, protecting the soft tissue envelope and gluteus medius tendon while maintaining axial alignment with the femoral canal.
Technical Articles
Latest Insights on Trochanteric Fixation Technology
Industry analysis on implant biomechanics, alloy performance, and surgical innovations.
Biomechanical Analysis of Helical Blade vs. Lag Screw in Osteoporotic Femurs
Evaluating load distribution, rotational displacement, and cut-out resistance under simulated gait cycles.
Management of Complex Subtrochanteric Fractures using Long PFN Systems
Surgical considerations for anterior bow matching and dynamic distal locking in reverse obliquity fractures.
IMPLANT METALLURGY
Ti-6Al-4V ELI Alloy Performance in Intramedullary Trauma Nailing
Why mechanical fatigue limit and notch sensitivity matter in long-term load-bearing intramedullary fixation.
Expand Your Trauma Portfolio with OEM Proximal Femoral Nails
Contact Orthi Medical Co., Ltd. for wholesale distribution pricing, technical specifications, and OEM samples at [email protected].