Auxein Sports Medicine — Advanced Joint Reconstruction & Arthroscopy Systems
CE MDR · US FDA 510(k) Cleared · ISO 13485:2016

Sports Medicine

Engineered for surgical precision: AUXILOCK® soft tissue repair systems, titanium & PEEK-OPTIMA™ suture anchors, bio-braided tapes, and 4K arthroscopic visual solutions serving 75+ global healthcare markets.

Invibio® PEEK-OPTIMA™ USA Material Implant-Grade Ti-6Al-4V ELI Titanium Cleanroom ISO 14644 Class 7 Packaged

AUXILOCK® Implant Material Technology

Auxein Medical’s AUXILOCK® sports medicine portfolio is engineered to provide orthopedic surgeons and procurement managers with uncompromising mechanical stability, biological compatibility, and versatile fixation options across diverse joint anatomies.

Titanium Ti-6Al-4V ELI

High pull-out force resistance and osteointegrative threading for heavy-load anatomical anchors.

PEEK-OPTIMA™ (Invibio USA)

Radiolucent polyetheretherketone matching cortical bone modulus to eliminate stress shielding.

PEEK-CF (Carbon Fiber Reinforced)

Enhanced structural toughness engineered for complex high-tension tendon reattachment.

BioBraid® UHMWPE Fibers

Ultra-high-molecular-weight polyethylene braided tapes providing superior knot security & soft tissue adaptation.

Joint Reconstructive Solutions

Comprehensive evaluation and surgical management systems designed for minimally invasive arthroscopy and soft tissue fixation across all major joint regions.

AUXILOCK Knee Reconstruction Anchors and Buttons

Knee Joint Repair

ACL/PCL femoral cortical fixation buttons, interference screws, and all-inside meniscal repair anchors designed for high pull-out load performance.

ACL/PCL Reconstruction Meniscal Repair
AUXILOCK Shoulder Suture Anchors and Knotless Fixation

Shoulder Arthroscopy

Threaded PEEK and Titanium suture anchors alongside knotless push-in anchors optimized for Rotator Cuff, Bankart, and SLAP lesion repairs.

Rotator Cuff Repair Knotless Anchors
AUXILOCK Hip Labral Suture Anchors

Hip Joint Solutions

Specialized low-profile knotless PEEK-CF push-in suture anchors designed to address femoroacetabular impingement (FAI) and labral reattachment.

Labral Repair Low Profile
AUXILOCK Small Joint Suture Anchors

Small Joint Fixation

Miniature titanium and PEEK suture anchors crafted specifically for delicate ligament reconstruction in hand, wrist, and elbow procedures.

Hand & Wrist Mini Anchors
BioBraid High Strength Suture Tapes

BioBraid® Suture Tapes

Ultra-high-molecular-weight polyethylene (UHMWPE) non-absorbable suture constructs providing optimized load distribution over soft tissue.

UHMWPE Fiber High Tensile
Foot and Ankle Syndesmosis Repair Kit

Foot & Ankle Repair

Advance Syndesmosis repair kits and Achilles tendon repair anchors built to enable accelerated post-operative weight-bearing stability.

Syndesmosis Kit Achilles Repair
Asterius 4K Arthroscopy Imaging Tower System

Asterius® 4K Visual Tower

Medical-grade 4K Ultra-HD camera control unit, LED cold light source, and diagnostic visualization tower for advanced arthroscopic surgery.

4K Ultra-HD LED Light Source
Arthroscopy Surgical Instrumentation Set

Arthroscopy Instrumentation

Precision-engineered passors, graspers, punches, and drill guides designed for seamless integration with AUXILOCK® implant insertion.

Ergonomic Handle Autoclavable

Precision Engineering & Global B2B OEM Supply

Auxein Medical integrates Swiss-type CNC multi-axis machining, automated optical inspection, and ultra-clean packaging environments to support international hospital distributors and orthopedic brand owners.

Rigorous Quality Testing

Every batch undergoes mechanical pull-out strength testing, fatigue evaluation, and dimensional verification according to ASTM and ISO standards.

ISO Class 7 Cleanroom Packaging

Implants are processed and double-sterilization packaged inside certified ISO 14644 Class 7 cleanroom facilities to guarantee sterility integrity.

OEM / ODM Customization Support

Tailored implant dimensions, custom surgical instrument sets, private labeling, and localized regulatory registration dossier assistance.

International Quality Certifications

Our manufacturing infrastructure is audited and compliant with global medical device regulatory frameworks, providing seamless hospital authorization and procurement.

US FDA 510(k) Cleared

Compliant with United States FDA quality systems and premarket notification clearances for surgical distribution.

CE Mark (EU MDR)

Certified under Regulation (EU) 2017/745 for sports medicine and joint reconstruction medical devices in Europe.

ISO 13485:2016

Internationally recognized Quality Management System specifically tailored for medical device design & production.

MDSAP Certified

Single Audit Program approval valid across United States, Canada, Brazil, Japan, and Australian regulatory authorities.

Frequently Asked Questions

Key insights for hospital procurement officers, orthopedic surgeons, and international device distributors.

What materials are utilized in Auxein's AUXILOCK® suture anchors?

Auxein’s AUXILOCK® anchors are manufactured from implant-grade Titanium (Ti-6Al-4V ELI), PEEK-OPTIMA™ (Invibio, USA), Carbon Fiber Reinforced PEEK (PEEK-CF), and high-strength UHMWPE BioBraid® suture tapes.

Are Auxein sports medicine implants cleared for distribution in Europe and the US?

Yes. Auxein Medical holds US FDA 510(k) clearances, European CE MDR certificates, ISO 13485:2016 accreditation, and MDSAP certifications, facilitating registration in over 75 countries worldwide.

Can Auxein supply custom surgical instrumentation and OEM packaging?

We provide full B2B contract manufacturing, customized tray layouts, private labeling, OEM/ODM development, and complete technical documentation to support global distributors.

Ready to Expand Your Sports Medicine Portfolio?

Partner with Auxein Medical for CE & FDA certified sports medicine implants, competitive OEM supply solutions, and direct factory distribution support.

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