Elevating Arthroscopic Surgical Outcomes
The structural axis of arthroscopic excellence. European-grade precision, designed for clinical excellence and sustainable healthcare value. Proudly operating from our headquarters in New York, USA to serve the global orthopedic community.
Pillars of Trust
Every anchor, screw, and instrument reflects a commitment to traceable quality and surgeon trust.
A Commitment to Global Compliance
Transparency & Roadmap
Our regulatory framework integrates ISO 13485 design and development controls with EU MDR conformity assessment procedures. Technical files document mechanical performance, shelf-life studies, and simulated use testing for suture anchors and meniscal repair devices. FDA establishment registration and device listing support U.S. market readiness alongside CE-marked European distribution.
Manufacturing Excellence
The Engineering Advantage
ISO Class 7 environmental monitoring governs every stage of PEEK molding and titanium turning in our certified production suites. CNC micro-milling and Swiss screw machining deliver repeatable geometry for knotless anchors and drill guides.
Material Integrity
Biomaterial Innovation
- Titanium: Grade 5 Ti6Al4V ELI
- PEEK: High-grade PEEK-OPTIMA™ polymers
- Bio-absorbables: PLDLA / TCP biphasic compounds
Validated Testing
Evidence-Based Biomechanics
Every implant design undergoes rigorous static & dynamic fatigue testing according to ASTM F543 standards for metallic medical bone screws.
Precision Process
Three validated stages transform raw biomaterials into OR-ready arthroscopy solutions.
Medical-grade PEEK Optima, absorbable PLGA blends, and Ti-6Al-4V ELI rod stock are procured from ISO 13485-approved vendors. Certificate of analysis review and dimensional verification precede any material release to production.
Injection molding presses form PEEK anchor bodies while CNC centers drill, tap, and counterbore mating features. Bar-fed Swiss lathes produce titanium screw shanks with validated thread pitch and cannulation concentricity.
CMM and vision-system inspection confirm implant geometry before Tyvek pouch sealing and terminal sterilization to SAL 10⁻⁶. Sterility test samples and dosimetry records accompany each released production lot.
Regional Insights: South America
Why surgeons across Colombia, Brazil, and Argentina are choosing AxenMedical for quality and value.
"The instrumentation is intuitive. It significantly reduced my surgical time for rotator cuff repairs. High quality at a fair price."
"Simple, effective, and reliable. The PEEK material holds up perfectly under tension. My go-to for shoulder repairs."
"Reliable fixation every time. The clinical evidence, robust material strength, and intuitive instrumentation speak for themselves."
Global Expansion
From proven success across Europe and the Middle East to transforming sports medicine in the Americas.
Advanced Composites
PEEK-OPTIMA™
Polyether ether ketone polymer with elastic modulus mimicking cortical bone for engaging stress-shielding prevention.
Bio-Composite
Proprietary blend of PLDLA & β-TCP designed for validated osteoconductivity and full absorption over 24 months.
Ti-6Al-4V ELI
Premium medical-grade titanium alloy (Grade 23) ensuring maximum fatigue strength for high-load applications.
✓ MRI-Conditional Compatibility
Our Story
Uncompromising dedication since 2018.
AxenMedical delivers structurally superior arthroscopic solutions built on decades of biomechanical research and precision manufacturing.
Engineered to Global Standards
Premium materials, micron-level machining, and uncompromising regulatory compliance.
Advanced Biomaterials
Medical-grade Titanium (Grade 23) and PEEK polymers deliver validated biocompatibility and long-term stability for every implant.
Micron-Precision Manufacturing
Using Swiss-type CNC machining, we maintain extreme tolerances (±0.005mm), ensuring flawless integration between implants and surgical instruments.
Verified Mechanical Strength
All anchors and screws undergo rigorous ASTM F543 testing, validating exceptional pull-out strength and torsional resistance under stress.
Global Regulatory Compliance
Manufactured under strict ISO 13485:2016 quality systems, our products carry the CE Mark (MDR) and achieve a pristine SAL 10⁻⁶ sterility assurance level.
Global Vision
The Americas: Our New Clinical Frontier.
US & LATAM Expansion
We are actively establishing regional logistics hubs in the United States and strategic partnerships across Latin America to provide real-time inventory and clinical support.
Clinical Collaboration
Join our clinical advisory board. We collaborate directly with surgeons to refine implant geometry based on the unique operative demands of the American market.
Frequently Asked Questions
Common questions about our technology and partnership process.
What materials are used in your implants?
We primarily use PEEK-OPTIMA™ and proprietary Bio-Composite materials that offer superior strength and biocompatibility, designed to mimic the natural elasticity of bone.
Are your products ISO certified?
Yes, AxenMedical operates under an ISO 13485 certified quality management system, ensuring the highest standards of safety and reliability.
Do you offer training for surgeons?
Absolutely. We provide comprehensive training programs, including cadaver labs and virtual surgical simulations, to ensure proficiency with our systems.
What is the typical lead time for orders?
Standard orders are processed within 24 hours. International shipping times vary but typically arrive within 3-5 business days via our logistics partners.
Can I request custom instrument sets?
Yes, we offer modular instrument trays that can be customized to your specific surgical preferences and procedural needs.
How do I become a distributor?
We are actively expanding our global network. Please use the contact form below to inquire about territory availability and partnership requirements.
What sterilization methods are compatible?
Our instruments are compatible with standard autoclave cycles. Implants are provided sterile-packed (Gamma or EtO) depending on the material.
Do you offer demo kits?
Yes, evaluation kits are available for qualified medical facilities. Contact our sales team to schedule a demonstration.
What is your return policy?
We offer a 30-day return policy for unopened, sterile products. Please refer to our Terms of Sale for detailed conditions.
Are these implants MRI safe?
Our PEEK and Bio-Composite implants are MRI-Conditional. Titanium components are also compatible but may cause minor artifacts depending on the sequence.
Seamless Integration
Designed for immediate OR readiness.
Sterile Packaging Solutions
All implants arrive pre-sterilized via validated Gamma or EtO processes, double-blistered for immediate safe transfer to the sterile field without delay.
Universal Instrument Compatibility
Engineered to work flawlessly with standard arthroscopic instrument sets, minimizing the need for proprietary hospital capital investments.
Request a Partnership & Evaluation
Select your professional role to route your inquiry to the correct department.