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
Quality-managed production, CE-marked device pathways, and sterile barrier packaging support clinical deployment.
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 arthroscopy parts and services do you provide?
AxenMedical supplies arthroscopy instruments, suture anchors, interference screws, compatible components, sterile-ready kits, and related clinical support for hospitals, surgeons, and distributors.
What materials are used in your implants?
Our implant lines commonly include medical-grade PEEK and biocomposite options selected for strength, imaging characteristics, and biocompatibility. Material certificates and IFU details are available for qualified accounts.
Are your products manufactured under an ISO 13485 quality system?
AxenMedical follows an ISO 13485-aligned quality management approach with documented processes intended to support safety, consistency, and hospital procurement review.
Do you offer surgeon or staff training?
Yes. We provide educational resources and can coordinate training support such as technical overviews, in-service sessions, and evaluation materials for qualified clinical teams.
What is the typical lead time for orders?
Standard orders are typically processed within one business day. International delivery times vary by destination and carrier; account teams can confirm current transit estimates.
Can I request custom instrument sets or kits?
Yes. Modular trays and procedure-oriented kits can often be configured to match surgical preferences. Share your procedure mix and preferred components through the contact form.
How do I become a distributor?
AxenMedical works with regional distributors. Use the contact form to inquire about territory interest, expected volume, and partnership requirements.
How are implants sterilized?
Implants are typically supplied sterile-packed using validated Gamma or EtO processes depending on the material and packaging configuration. Instruments follow IFU guidance for compatible reprocessing where applicable.
Do you offer evaluation or demo kits?
Evaluation kits and sterile samples may be available for qualified medical facilities. Contact our team to discuss eligibility and scheduling.
Are PEEK and biocomposite implants MRI-compatible?
PEEK and many biocomposite implants are commonly used when reduced metal artifact is preferred. Always follow the product IFU and your imaging protocol for MRI labeling and conditions.
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.