Metal Materials

Nitinol

Each medical-grade Nitinol material is composed of nearly equal atomic percentages of nickel and titanium, complying with GB 24627 and ASTM F2063 standards, making it suitable for surgical implants. To meet the needs of various specialized applications, we also offer ternary or multi-component Nitinol alloys. At Fortune Medical, all raw materials undergo third-party incoming inspections to ensure that chemical composition, phase transition temperatures, material uniformity, and microstructure meet the required standards.

01. NiTi/Ultra-Pure Nitinol Tube

Nitinol alloys, known for their shape memory and superelastic properties, are key materials for interventional medical devices. Nitinol tubes, after precise cutting and processing, can be made into various medical devices and are currently used in neuro-interventional stents, catheters, peripheral stents, dental products, and more. Ultra-pure Nitinol materials, with higher purity, better biocompatibility, mechanical properties, and fatigue resistance, are primarily used for long-term implantable devices. They are widely applied in high-end devices such as artificial heart valves, intracranial stents, and peripheral stents.

Product Advantages

● Uniform wall thickness;

● High precision;

● Grain size ≥ 8;

● Smooth surface：Outer surface Ra ≤ 0.1 μm, inner surface Ra ≤ 0.6 μm;

● High material purity：Porosity and metallic inclusions ≤ 10.0 μm; porosity and non-metallic inclusions area percentage ≤ 0.5%

● Excellent fatigue resistance, used in valve stents, peripheral stents, neuro-interventional stents, and more.

● Outer diameter range: 0.18-16.0 mm;

● Wall thickness range: 0.025-3.0 mm;

● Complies with ASTM F2063 and GB24627 standards;

Element content	Ni	C	Co	Cu	Cr	H	Fe	Nb	N+0	Ti
Mass fraction%	54.5-57.0	≤0.050	≤0.050	≤0.010	≤0.010	≤0.005	≤0.050	≤0.025	≤0.050	Margin

Test items	Test result
Tensile strength(MPa)	≥1000
Rate of elongation(%)	≥10
4% Platform Stress (MPa)	≥380
6% residual deformation (%)	≤0.3
Austenitic transition end temperature Af(°C)	≤15

Outside diameter range(mm)	Outside diameter tolerance(mm)	Inside diameter tolerance(mm)	Wall thickness range(mm)	Wall thickness tolerance(mm)
0.18≤0D≤0.5	±0.002	±0.005	0.025≤WT≤0.12	±0.003
0.5<0D≤1.0	±0.005	±0.008	0.025≤WT≤0.30	±0.005
1.0<0D≤3.0	±0.010	±0.010	0.025≤WT≤0.40	±0.008
3.0<0D≤6.0	±0.010	±0.015	0.050≤WT≤1.05	±0.008
6.0<0D≤9.0	±0.015	±0.020	0.007≤WT≤2.00	±0.008
9.0<0D≤12.0	±0.020	±0.020	0.10≤WT≤2.00	±0.010
12.0<0D≤16.0	±0.020	±0.030	0.10≤WT≤3.00	±0.010
Inner surface：clean state,oxidation state External surface：grinding state,oxidation state

Product Data：Chemical Composition

Product Data：Mechanical property

Product Data：Delivery specification

02. Nitinol wire

Nitinol wire has superelasticity and shape memory, and is widely used in clinical applications. It has been used to weave stents, guide wires, device delivery systems, stone removal baskets, medical springs, sutures, etc.

Product Advantages

● Diameter range: 0.030-5.0mm；

● Comply with ASTM F2063 and GB24627 standards

Element content	Ni	C	Co	Cu	Cr	H	Fe	Nb	N+0	Ti
Mass fraction%	54.5-57.0	≤0.050	≤0.050	≤0.010	≤0.010	≤0.005	≤0.050	≤0.025	≤0.050	Margin

Test items	Test result
Tensile strength(MPa)	≥1300
Rate of elongation(%)	≥10
4% Platform Stress (MPa)	≥480
6% residual deformation (%)	≤0.5
Austenitic transition end temperature Af(°C)	10±7

Product Data：Chemical Composition

Product Data：Mechanical property

Wire diameter(mm)	Wire diameter tolerance(mm)	Outer surface state
0.030-0.070	±0.003	Clean black state Dark brown Clean state Black faced state Bright state Superbright state Ground state Dark blue Light brown
0.070-0.140	±0.004
0.140-0.250	±0.005
0.250-0.350	±0.007
0.350-2.000	±0.010
2.0-5.0	±0.020

Product Data：Delivery specification

03. Nitinol Ropes

NiTi ropes made of two or more NiTi alloy wires not only maintain the super elastic properties of NiTi materials, but also have the excellent flexibility and maneuverability of stainless steel wire ropes. and miniaturization characteristics.

Surface state

● Black surface oxidation state ● Light oxidation state (golden to brown)

Upper Plateau Stress

σload Mpa

UTS
σb Mpa

Elongation
σ%

Permanent set

after 6% strain %

Active Af °C

>350MPa

>1000MPa

>10%

<0.5%

10-10~20℃

Structure		Diameter Range(mm)	Diameter Tolerance(mm)
	1*2	0.15~0.30	+0.03/-0
	1*3	0.20~0.45 0.45~0.60	+0.03/-0 +0.06/-0
	1*7	0.18~0.45 0.45~0.70 0.70~1.20	+0.03/-0 +0.06/-0 +0.10/-0

Mechanical properties

Rope diameter tolerance

Typical applications

● Orthopedic instruments, dental instruments, spine, endoscope control, snare, basket

04. NiTi Flat Wire

Shape:

● Nitinol Flat wire ● Nitinol square wire

Dimensional tolerances: according to the finished size range

γ	Thickness	Tolerance of Thickness
2<γ≤7	0.013≤T≤0.05mm	±0.005mm
	0.005<T≤0.8mm	±0.1Tmm

Mechanical properties:

● UTS ≥1100Mpa ● Elongation ≥29% ● UPS ≥2480Mpa ● Af 10±10°C ● Strain <0.5

Surface state Options:

● Black ● Light oxide(Amber) ● Oxide free

Packaging of wires:

Spool: wire must be wound evenly on the spools, without breaks or tangles；Fixed Length Fortune Medical an cut wire at customer's requested length；Coil

Dimensional tolerances of the thickness (y: Width-thickness ratio T: Thickness)

γ	Width	Tolerance of Thickness
2<γ≤7	0.01≤W≤2.5mm	±0.1Wmm
	0.045<W≤0.1mm	±0.01mm

Dimensional tolerances of the width (y: Width-thickness ratio W: Width)

Metal Processing

Fortune Medical is a specialized company engaged in precision machining, five-axis machining, complex part processing, titanium alloy part machining, engineering plastic part machining, and non-standard part processing. It offers one-stop modular assembly services to clients, with a focus on the medical industry.

01. PTFE coated mandrel

Fortune Medical specializes in providing medical functional coating process services, including lubrication, developing, insulation, and other functionalities. We offer OEM coating services, with existing production lines such as the guidewire-core shaft spraying line, fully automated continuous dipping line, flat wire spring tube post-coating line, and (gold) developing coating line. Currently, we have 4 coating production lines and offer complete coating process solutions, with customized services available based on customer requirements.

Continuous Dipping Coating Line

● Materials: Stainless steel, Nitinol

● Size: >0.1mm

● Coating Thickness: >0.003mm

● Colors: Green, Black

Guidewire - Mandrel Coating Line

● Materials: Stainless steel, Nitinol

● Size: >0.15mm

● Coating Thickness: >0.005mm

● Colors: Green, Black, Gray, etc.

Spring Tube Post-Coating Production Line

● Materials: Stainless steel

● Length: 0.1-3m

● Shape: Flat wire, Round wire, Tapered wire

● Coating Thickness: >0.004mm

(Gold) Developer Coating Line

● Materials: Stainless steel, Nitinol

● Categories: Micro guidewires, Stents, Basket nets

● Coating Thickness: Customized

02. High-precision medical parts processing

Processing technology: plastic processing (stamping, bending, 3D printing), precision machining (CNC machine, five-axis machine tool), surface treatment (electrolytic polishing, anodizing) Processing equipment: femtosecond laser cutting machine,German DMGMORI five-axis machining center, high-end slow wire cutting and other advanced equipment Product features: strict tolerance, complex geometry, smooth surface, high biocompatibility, minimum order quantity 1 piece Processing materials: pure titanium and titanium alloys, other medical metals

Absorbable Materials

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Metal Materials

It is very difficult to produce bioabsorbable medical devices. Controlling humidity and material degradation during the production process requires specialized equipment and process control to ensure the quality of finished instruments. In addition, other bio absorbable manufacturers only participate in one step of the manufacturing process (i.e. polymer, extrusion, textile, etc.), thus forming a complex multi supplier supply chain. Fortune Medical is the only vertically integrated partner that uses a single source of bioabsorbable polymers from finished medical devices to components.