NITINOL EXPERTISE

Precision Nitinol Manufacturing for Demanding Surgical Applications

With over 20 years of specialized experience, D&R Products is a recognized leader in the precision manufacturing of Nitinol-based medical components, serving OEMs, design engineers, and technical procurement teams across the orthopedic, podiatric, and interventional device sectors. Our deep expertise in Nitinol’s unique material properties—superelasticity, shape memory effect, and biocompatibility—allows us to engineer complex components that meet exacting performance standards under the most demanding clinical conditions.

As an FDA-registered and ISO 13485:2016-certified supplier, we offer full regulatory alignment, end-to-end traceability, and documented process validation across all production stages. Our in-house engineering, machining, and quality control teams work closely with clients to ensure design intent, manufacturability, and compliance are tightly integrated from concept to finished part.

nitinol medical device manufacturing

1/1

Advanced Nitinol Product Portfolio

Our Nitinol capabilities are focused on manufacturing highly specialized components for surgical fixation, orthopedic reconstruction, and soft tissue anchoring. Key products include:

Superelastic Nitinol Staples
Designed for dynamic compression and load-sharing in bone fixation procedures, these staples offer excellent fatigue resistance and recovery force. Our superelastic designs maintain consistent clamping force even under cyclic loading, supporting applications such as osteotomies and arthrodesis in small bones.

Memory Nitinol Staples
Thermally activated to change shape at body temperature, memory staples enable controlled deployment and fixation with minimal instrumentation. We customize transition temperatures, mechanical profiles, and geometries to meet procedure-specific requirements.

K-Wires & Guide Pins (including Cobalt-Chrome [CrCo] variants)
Manufactured with precision ground finishes and tight dimensional tolerances, our K-Wires support fracture fixation, implant navigation, and stabilization procedures. CrCo versions offer enhanced strength, corrosion resistance, and radiopacity for advanced surgical visibility.

Varisation Staples
Our proprietary line of Varisation Staples is designed to meet complex angular correction and soft tissue tensioning requirements in foot and ankle surgery. These devices combine shape memory precision with surgeon-friendly delivery and tactile feedback.

Why D&R for Nitinol Manufacturing?

Deep Material Knowledge:
We understand Nitinol’s complex behavior—transformation temperatures, fatigue performance, and processing sensitivity—and incorporate this into every step of design and manufacturing.

Precision Engineering & Validation:
Our components are manufactured with tight tolerances (as low as ±0.0002”) and undergo rigorous process validation, including mechanical testing, pull strength, and fatigue life assessments.

Flexible Production Volumes:
We support both low-volume prototyping and scalable production with consistent quality, enabling rapid design iterations without compromising process controls.

Integrated Secondary Operations:
Services such as electropolishing, passivation, laser marking, and sterile packaging are available in-house, minimizing lead time and ensuring post-processing compatibility with implantable devices.

When device integrity, biocompatibility, and clinical performance are non-negotiable, D&R Products stands as a trusted partner in precision Nitinol manufacturing—delivering solutions that meet the challenges of modern surgical innovation.

BACK TO CAPABILITIES