Medical-grade screw customization specialist
Precision, Cleanliness & Reliability for Medical Device Fastening. SST provides biocompatible, non-magnetic & corrosion-resistant screws and miniature fasteners meeting stringent standards for critical medical equipment applications.
Dedicated standards for medical devices
Support FDA 510(K)/CER MDR certification, preferred supplier of orthopaedic implants/endoscopes/imaging equipment
Dedicated standards for medical devices
✅ Implantable clean room: ISO Class 5 clean environment
✅ Whole process traceability: each screw is individually UDI coded
✅ Sterilization support: oxirane gamma rays high pressure steam
Why did Medtronic choose our cytotoxicity test?
PASS ISO 10993-5 cytotoxicity/ISO 10993-10 stimulation allergy test suite, support third party retest
Medical testing system
1.Detection of heavy metals in raw materials by ICP-MS
“ICP-MS accurate screening, 23 heavy metals exceeded zero”
2.Process particulate control < 100 particles/M 3
“Dynamic cleaning monitoring, particle count < 100/m3 to ISO 5”
3.Sterility test of finished product
“Oxirane validation, zero bio-load detected.”
Medical optimization techniques
🔹Anti-fretting corrosion： Anodic oxidation + titanium nitride composite coating
🔹Non-slip tooth design： double-headed triangle thread (patent no. ZL2023XXXXXXXX)
🔹Rapid Response： 48-hour emergency sample delivery
Parameters | Conventional turning | The technology of walking heart machine |
Cost | ￥15.8 per piece | ￥9.3 per piece |
Production rate | 80 pieces per hour | 500 pieces per hour |
Surface Roughness | Ra1.6 | Ra0.4 |
More stringent cleanliness promises than the operating room
12-hour root cause analysis, 72-hour global replacement in place for unexpected recalls
Exclusive Medical Insurance
🔹 Free Biocompatibility test template
🔹 Annual Quality White Paper for strategic customers
🔹 Support VHP sterilization packaging customization
Emergency level | Response time | The solution |
Type one recall | 1 hour | Full batch replacement + public notice |
The second kind of bad | 4 hour | Emergency deployment of regional inventory |
Type 3 complaints | 8 hour | Door-to-door inspection by technical team |
Strict Quality Control
36 years general work team check, 100% simulation of actual combat environment, from the source to eliminate the risk of broken head/sliding teeth.
Data Detection
We will carry out a lot of screw products sampling test, to ensure that customers get our qualified products.
100,000 class clean workshop live broadcast, witness the birth of medical screws
German B + S automatic lathe + American Hubbard ultrasonic cleaning line, accuracy exceeding ISO 13485 standard
Standards for medical intelligence
✅Implant roughness ra 0.8
✅particulate contamination < 5 μm
✅< 10 cfu/g of initial contaminating bacteria in packaging
✅Material: titanium material, food grade material
✅Dimensions: tolerance ± 0.1 mm
✅Smooth appearance, beautiful, finish ≤0.8
✅Environmental Protection: food grade
Support MDSAP multi-national certification to meet China, US and EU market access
Production Process
Intelligent optimization process, precision intelligent manufacturing each fastener
The price dropped 60% from first prototype to million-dollar production
Sample free verification (limited to Class III medical devices) , the annual strategic customers enjoy QC services in the factory
Health care purchasing commitment
🔹10-year warranty period
🔹2 quality issues 48-hour global replenishment
🔹3 free of charge to provide sterilization verification report
The 2023 flew through the FDA to check for zero defects
01.
Material cost accounted for 38%
02.
clean process 27%
03.
etection cost 22%
04.
Profit 13%
Custom Pricing
Free sample verification, maximum 15% refund after mass production, product price commitment signed online
Stage | Unit Price | Lead Time | Exclusive rights and interests |
Samples (1-10) | $ XX.XX | 3 days | Free of mould fee |
Small Batch (1000) | $ XX.XX | 7 days | Send the Destructive testing |
Mass production (100,000 +) | $ XX.XX | 15 days | General factory acceptance in factory |
Products
Build Your Custom Solution in 3 Steps
1. Select Your Groove Type – Optimize for Strength or Flexibility
Choose from 10+ engineered groove profiles – from standard V-grooves for general applications to specialized T-slots for heavy machinery.
Our CNC machining ensures ±0.005mm tolerance for perfect load distribution.
Pro Tip: 90% of industrial clients select helical grooves for vibration resistance.
2. Choose Tooth Type: Precision Cutting or Smooth Engagement
Select triangular teeth for high-speed cutting (ideal for aerospace alloys)or rounded teeth to reduce wear in repetitive assembly (common in automotive).
Custom tooth pitch options available – Our engineers recommend 2.5mm pitch for 80% of polymer applications.
3. Design Your Head Shape: Functional Aesthetics Meets Installation Efficiency
From low-profile hex heads (ISO 4762) to tamper-resistant Torx designs, select shapes that align with your tooling ecosystem.
Pro Tip: 70% of clients pairing button heads with recessed grooves reduce installation time by 40%.
Precision-engineered from concept to delivery: Streamlined 5-stage process with 1-hour response, 72h prototyping, and ISO-certified quality control.
1.Upload Drawing
Submit CAD/PDF drawings or send samples online.
2. Your request
Shape, material, surface finish, quantity, size。
3. Rapid Prototyping
CNC precision machining + 3D printing synchronous start-up, 72 hours to deliver functional samples。
4. Provide a report
To provide you with a customized product inspection report and production cost forecast.
5. Mass Production & QC
The whole process of digital production, every 500 pieces of full inspection once, support SGS third-party inspection, 7-15 days to complete order delivery.