Versatile, corrosion-resistant stainless steel ideal for
structural, industrial, and fabrication applications. Available
in angles, bars, channels, flats, and beams.

The medical device and life sciences sectors demand materials that perform beyond structural or chemical specifications alone. Biocompatibility, sterilizability, corrosion resistance to body fluids and sterilization chemicals, and consistent mechanical properties from heat to heat are baseline requirements.

Stainless steel and titanium are the two dominant metallic material families in medical applications. 316L stainless steel has been the workhorse of surgical instrument and equipment manufacturing for decades. Titanium alloys, particularly Ti-6Al-4V ELI (Grade 23), have become the standard for load-bearing orthopedic and dental implants due to their exceptional biocompatibility and osseointegration properties.

Stainless Shapes works with medical device engineers, contract manufacturers, and procurement teams to supply these materials with the documentation and specification knowledge that medical applications require.

316L stainless steel’s austenitic structure and passive chromium oxide surface layer provide outstanding resistance to corrosion by body fluids, saline, and the aggressive chemical environments of steam autoclave and EtO sterilization cycles. Its non-magnetic characteristics, which are important for MRI environments, ease of machining to fine tolerances, and ability to achieve very smooth surface finishes make it ideal for surgical instruments and medical equipment.

Titanium alloys offer a unique combination of low modulus of elasticity (closer to bone than steel), exceptional biocompatibility with essentially zero ion release in physiological environments, and outstanding fatigue resistance. These properties make them the implant material of choice for orthopedic, dental, and spinal applications. Grade 23 Ti-6Al-4V ELI features tighter interstitial element controls, with lower iron, oxygen, carbon, and nitrogen than standard Grade 5, improving fracture toughness for fatigue-critical implant applications.

• Orthopedic Implants: Grade 23 Ti-6Al-4V ELI and 316L F138 for hip stems, knee components, bone screws, plates, and intramedullary nails requiring biocompatibility and fatigue resistance.
• Dental Implants and Instruments: CP titanium (Grades 1 and 2) for osseointegrating dental fixtures. 17-4 PH and 420 stainless for dental hand instruments and prosthetic components.
• Surgical Instruments: 420, 440C, and 316L for scissors, forceps, clamps, retractors, and needle holders requiring corrosion resistance across repeated autoclave sterilization cycles.
• Medical Equipment: 316L sheet, bar, tube, and structural sections for hospital furniture, surgical tables, imaging equipment frames, and diagnostic device housings.
• Life Sciences and Laboratory: 316L and 304 stainless steel for laboratory equipment, analytical instrument housings, chromatography components, and pharmaceutical process equipment.
• Drug Delivery and Minimally Invasive Devices: Precision 316L tube and bar for hypodermic needle stock, cannula, catheter guide wires, and minimally invasive surgical device components.

• Implant-Grade Availability: We stock and can source ASTM F138-Grade 316L and ASTM F136 Grade 23 titanium with the tighter chemistry controls required for implant applications.
• Material Test Reports: Full chemical composition and mechanical property certification for every heat, supporting your device history record and quality system documentation.
• Specification Expertise: Our team understands the difference between ASTM F138 and commercial 316L, and between Grade 5 and Grade 23 titanium, and can help you identify the right specification.
• Small Quantity Supply: Medical device development and prototyping programs often require smaller quantities than commodity distributors accommodate. We work with customers across the full development lifecycle.
• Consistent Heat Traceability: We maintain heat traceability throughout our supply chain, enabling customers to trace materials back to mill certifications when required by their quality systems or FDA documentation requirements.
• Multiple Forms Stocked: Bar, plate, sheet, and tube across multiple grades, reducing the number of vendors your procurement team needs to manage for a single device program.

What is the difference between standard 316L and ASTM F138 implant-quality 316L?

ASTM F138 imposes tighter compositional limits on key elements, particularly sulfur, phosphorus, silicon, and nickel, and also limits inclusion size and type to reduce stress concentration points that could initiate fatigue cracks. Standard commercial 316L meets the ASTM A276 or A479 specification, which has broader allowable ranges for some elements. For implanted devices, ASTM F138 is the required standard. For surgical instruments and non-implanted equipment, commercial 316L meeting ASTM F899 is generally appropriate.

What is the difference between Ti-6Al-4V Grade 5 and Grade 23 (ELI)?

Grade 23 is the Extra-Low Interstitial (ELI) version of Ti-6Al-4V. It has tighter maximum limits on oxygen (0.13 percent vs. 0.20 percent), iron (0.25 percent vs. 0.30 percent), carbon, and nitrogen compared to standard Grade 5. These lower interstitial element levels improve fracture toughness and fatigue crack growth resistance, properties that are critical in cyclic load-bearing implant applications. Grade 5 is appropriate for non-implanted instruments and device components. Grade 23 is specified for implants.

Can you provide material certified to ISO 10993 biocompatibility?

ISO 10993 is a biocompatibility testing standard for medical devices. It governs testing protocols, not material composition directly. While we can provide material conforming to ASTM F138, F136, F67, and other implant material standards that are widely accepted as meeting biocompatibility requirements, the ISO 10993 biocompatibility evaluation of a finished device is the responsibility of the device manufacturer. Our MTRs and chemistry certifications support your biocompatibility documentation file.

Do you supply titanium tubes for minimally invasive surgical devices?

Yes. We stock and can source titanium tube in Grade 5 and Grade 23 for minimally invasive device applications. Please contact us with your specific outer diameter, wall thickness, and length requirements, and we will confirm availability and provide a quote.