Orthopedic OEM Partner Trusted by Global Innovators
Built on firsthand experience in leading global orthopedic companies, we help brands manufacture innovative, reliable, cost-effective implants and surgical instruments in China.
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.
17 years in orthopedic product development & manufacturing
Former Zimmer Biomet Engineer & Medtronic Quality Manager. Deeply involved in Design Transfer Projects and New Product Development for Joints & Spine Implants & Instruments .
Experienced in FDA Inspection (2×). In-depth knowledge of ISO 13485 & FDA QSR 820
From initial design concept to scalable production, we turn complex medical innovations into reliable, market-ready realities.
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 – USA Spine Company
US spine innovation leader focusing on advanced 3D-printed interbody & procedural systems.
"Design refinement to volume scale" partnership model.
Key Achievements:
✅ DFM for Additive Manufacturing:
Optimized complex 3D-printed titanium porous structures and provided rapid prototyping to drastically shorten development cycles
✅ Special Process & Post-Processing Validation:
Pre-validated critical thermal and surface finishing processes to ensure smooth transition from prototype to compliant mass production
✅ Multi-Class Spine Manufacturing:
Delivered complete turnkey solutions across Class I/II surgical instruments and Class III 3D-printed spinal implants under a unified QMS
✅ Cost & Design Optimization:
Lowered unit production costs through optimized printing layouts, post-machining efficiencies, and reduced raw material waste
Case 3 – Harvard Medical Shool Doctor Professor 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.
Deep Gun Drill Machine
Deep gun drilling enables precision, high-straightness deep hole machining for orthopedic implants (like cannulated screws and intramedullary nails) and surgical instruments.
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 or GTAW/TIG
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.
DLC Coating
Applying Diamond-Like Carbon (DLC) coatings to orthopedic medical devices significantly reduces friction, wear, fretting, and corrosion, thereby enhancing implant performance and longevity.
TiN Coating
Featuring a distinctive gold color, superior substrate adhesion, and excellent chemical stability through multiple cleaning and sterilization cycles, TiN coating serves as an ideal choice for medical instruments.
Anodising Coating
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. 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 (10+ units scalable to 10,000+)
- Traceability protocols meeting FDA & MDR Regulation requirements
3. Drawing 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.
4. Prototype Development & Validation
Speed & Agility: Emphasizes fast turnaround times to bring your orthopedic implant and instrument concepts to physical evaluation quickly.
Special Process Consideration: Proactively addresses critical medical manufacturing operations (like coatings, heat treatment, welding or cleaning) that demand stringent validation and quality control.
Mass Production Readiness: Bridges the gap between initial design and full-scale manufacturing, ensuring a smooth, de-risked transition to commercial volume.
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.