Orthopedic OEM Partner Trusted by Global Innovators
From design to FDA-compliant manufacturing we help orthopedic startups and brands turn ideas into reliable, affordable products.
Why Choose Us?
Dual-certified facilities (ISO 13485 Certified), fully regulation compliance to FDA 21 CFR Part 820 & EU MDR.
Turnkey solutions from design optimization to mass production, our design and manufacturing experts will strongly support your diverse needs.
Rapid response capability – 98% on-time delivery rate for urgent orthopedic implants & instruments
Our Team
Proven Experience in Orthopedic Contract Manufacturing
Lyntop Medical bridges the gap between design and manufacturing for global orthopedic innovators.
Our team combines engineering know-how, regulatory experience, and a strong manufacturing base in China.
10+ years in orthopedic product development & manufacturing
Former Zimmer Biomet Engineer & Medtronic Quality Manager. Deeply involved in Design Transfer Projects and New Product Development. Experienced in FDA Inspection (2×)
In-depth knowledge of ISO 13485 & FDA QSR 820
Successful Case Studies
Real Projects. Real Results.
Case 1 – European IM Nail Company
European startup specializing in orthopedic device innovation with no manufacturing capabilities
"They design - We build" partnership model.
Key Achievements:
✅ Full Production Scale-up:
Transitioned their patented intramedullary nail system from new product to FDA/CE-compliant mass production
✅ Multi-class Device Expertise:
Simultaneously manufactured Class I & II instruments & Class III implants under single quality management system
✅ Sterilization Integration:
Implemented ISO 11137 Gamma sterilization processes for ready-to-use surgical kits
✅ Cost Optimization:
Reduced unit production cost by 52% vs. EU manufacturers while maintaining ISO and ASTM standards
Case 2 – Harvard Medical Doctor Team
Harvard-affiliated surgical team developing low-cost trauma care solutions for underdeveloped areas, such as Africa. This also aligns with Lyntop's mission. Our mission is to make high-quality orthopedic medical devices accessible and affordable across the globe.
Mission-critical Support:
🛠️ Design-to-Reality Translation:
Engineered functional external fixation system at extreme low cost (75% below US market alternatives)
📋 Regulatory Navigation:
Provided international registration roadmap and ISO 13485 gap analysis for future commercialization
Our Advanced Factory
Cutting Edge Equipments. Talent and well trained Employee.
Mazak Machine: 5-Axis CNC
High-precision, heavy-duty CNC machines are known for rigidity and robust construction. Ideal for complex machining of large parts requiring high accuracy and stability.
HAAS Machine: 3+2 Axis
Cost-effective, user-friendly CNC machines for general-purpose machining. They offer a good balance of performance and affordability for smaller shops and startups.
Citizen Swiss Machine
Highly reliable and versatile CNC lathes particularly focused on Swiss-type machining. They excel in producing small, intricate parts with demanding tolerances.
EDM Machines
EDM(Electrical Discharge Machining) carves intricate shapes in tough implant materials, ensuring flawless fit and function for lasting patient recovery.
Vacuum Heat Treatment
Enhances the strength and corrosion resistance of orthopedic instruments by heating and cooling them in an oxygen-free environment, ensuring durability and biocompatibility
Laser Welding
A precision welding technique that uses a high-energy density laser beam as a heat source to melt materials and create strong bonds.
Electro-polishing
A finishing process that uses a controlled electrochemical reaction to smooth metal surfaces, enhancing their luster and corrosion resistance.
Passivation
A chemical treatment that forms a protective oxide layer on a metal surface, significantly improving its resistance to corrosion.
Tumbling
Imagine a gentle buffing, smoothing out rough edges and leaving a gleaming finish. Polishing utilizes abrasive materials or wheels to achieve a highly reflective, smooth surface.
Blasting
This method can create a rougher, textured surface for improved grip, remove rust or paint layers, or prepare surfaces for further treatments like painting or anodizing.
Anodising
After treatment, an oxide layer will be formed on the material surface. The oxide layer can prevent corrosion, reduce the risk of failure, and adverse reactions within the body.
Chrome Coating
It is a highly beneficial surface treatment for the instruments. By applying a thin layer of chrome onto the surface, it offers excellent corrosion resistance and protecting the instruments from damage.
Experienced Orthopedic System Category
Products Meet Highest Quality And Regulations
Spine
Anterior Cervical Interbody System
Posterior Cervical Fixation System
Laminoplasty Fixation System
Posterior Spinal Fixation System
CoCrMo Spinal Fixation System
Minimally Invasive Spinal System
Vertebral Expansion Ballon Catheter System
Inter Spinous Device
Titanium Mesh Cage
Peek Cage
Trauma
Intramedullary Nail System
Rib Plate System
Femoral Neck Internal Fixation System
Hollow Compression Screw System
Metal Cable System
Metal Bone Needle System
Sports Medicine
All-Suture Anchor
Meniscal Repair Device System
PEEK Interference Screws
Stapler
Suture Buttons
Non-absorbable Sutures
Threaded Cannula
Shaver Blade and Burr
Suture Passers
Suture Passer and Needles
Knot Pusher and Suture Cutter
Graft Preparation System
How We Work With You
1. Initial Engagement & Needs Assessment
We initiate contact to comprehensively understand your design specifications, target markets (e.g., FDA/CE compliance requirements), and production timelines. Our engineering team collaborates with your designers to align technical parameters with manufacturing feasibility.
2. Technical Review & Design Optimization
Leveraging 20+ years of orthopedic device expertise, we conduct a 360° technical evaluation of your CAD designs. Our proprietary simulation tools optimize materials (e.g., titanium alloys/Stainless Steel/PEEK polymers) and manufacturing processes (CNC machining/Post Treatment) while ensuring compliance with ISO 13485 standards.
3. Contract Finalization & IP Protection
A legally binding NDA and OEM agreement will be executed, incorporating:
- IP safeguards with encrypted design file management
- Flexible MOQ options (100+ units scalable to 10,000+)
- Traceability protocols meeting EU MDR Article requirements
4. Prototype Development & Validation
Within 15-25 working days, we deliver functional prototypes accompanied by:
- Material certification reports (ASTM F136/F1295)
- Dimensional inspection records (±0.005mm accuracy)
- Sterilization validation data (ethylene oxide/radiation)
5. Full-Scale Production & Quality Assurance
6. Rigorous Inspection & Documentation
7. Logistics Coordination & Aftercare
Contact Us
Let's start a conversation about how to work together to improve orthopedic surgeries.
Our dedicated team is at your service 24/7. Don't hesitate to reach out.