Redefining Orthopedic Surgical Technology
Unlocking predictable outcomes in minimally invasive arthroscopy. European-grade precision, designed for clinical excellence and sustainable healthcare value. Proudly operating from our headquarters in Vancouver, Canada to serve the global orthopedic community.
Pillars of Trust
Material traceability, cleanroom discipline, and clinical feedback loops anchor our quality culture.
A Commitment to Global Compliance
Transparency & Roadmap
We maintain ISO 13485-compliant document control for work instructions, device master records, and batch production records across cleanroom operations. EU MDR Person Responsible for Regulatory Compliance oversight ensures timely submission of vigilance reports and field safety notices. FDA user fee submissions and RTA checklists are prepared for each new arthroscopy device filing.
Manufacturing Excellence
The Engineering Advantage
ISO Class 7 cleanrooms support micro-injection molding of PEEK components followed by CNC drilling and Swiss lathe threading operations. Instrument handles and implant bodies share common quality gates before advancing to sterilization.
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
Where biocomposite chemistry, CNC precision, and SAL 10⁻⁶ converge.
Our procurement team secures PEEK, absorbable biocomposites, and orthopedic titanium with complete chain-of-custody documentation. First-article material testing confirms modulus, strength, and biocompatibility before scale production.
Complex anchor wing geometries emerge from precision molding followed by CNC flash removal and surface conditioning. Instrument handles are CNC machined from solid bar and overmolded with biocompatible grip polymers where required.
Pre-sterilization bioburden assessment and post-sterilization sterility testing validate SAL 10⁻⁶ for every arthroscopy implant family. Optical and tactile inspection reject non-conforming units before they enter the sterile supply chain.
Regional Insights: South America
Recurring themes from practitioner feedback across our South American supply network.
"Finally an affordable option that doesn't compromise on anchor strength. The knotless system fits our workflow well."
"The biocomposite material has worked well in our practice. We are happy with the switch."
"Responsive support and useful training materials. The quality is evident from the first use."
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 2016.
KeyholeMedical unlocks predictable surgical outcomes through purpose-built minimally invasive arthroscopic instrumentation and implants.
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
We combine CE-oriented device documentation with practical sterile-ready logistics for OR teams.
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?
KeyholeMedical 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?
KeyholeMedical 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?
KeyholeMedical 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.