Traceability: The Starting Point

Every prosthesis and every medical device must be uniquely identifiable throughout its entire lifecycle. It was this need that led Sofab Orthopédie, a major holding company based in the Rhône-Alpes region, to reach out to Sisma: to laser-mark prostheses and other metal medical devices while maintaining the high quality and meeting the stringent requirements of the medical field, all while streamlining production.

Marking is the foundation of UDI (Unique Device Identification) traceability [Learn More], as required by FDA regulations and the EU MDR.

The customer’s goal was clear: a stable marking process on a reliable machine, with a high degree of automation and flexibility. The system operates 5 days a week, in two 8-hour shifts.

The Challenge: Different Parts, Same Standards

Versatility. The project involves five very different product families: femoral heads, tibial stems, double-mobility cups of various sizes, other prostheses, and surgical guides. A single machine must handle parts with different geometries, dimensions, and implant positions.

Repeatability and precision. The customer requires medical-grade blackening marking: chemical resistance and excellent legibility on cobalt-chromium, titanium, and stainless steel. All of this must be achieved with very short cycle times to increase productivity.

Integration. The system must communicate with the company database via SQL queries, automatically load marking projects, and automatically detect the position of components.

The Sisma Solution: BSP Pico with WH10 Vertical Magazine

To meet these needs, we proposed the BSP Pico laser marker combined with the WH10 automatic loading magazine featuring 10 trays. The magazine increases productivity and the level of automation, and enables unattended operation. The software is integrated with the customer’s SQL database: it retrieves data, generates the UDI marking, and automatically loads the marking projects.

Materials and Finishes: Testing Readability

In consultation with the customer, we tested four materials, developing two sets of parameters for each, in search of the best quality in the shortest possible cycle time.

The benchmark. The sample is a partially polished metal disc. We marked two 2D codes on both the polished and the matte sides for each set of parameters. The result is four different levels of readability, to verify how the finish and parameters affect reading.

Accuracy, repeatability, and part recognition: CVS and Pattern Matching

Dimensional accuracy. On the X2CrNiMo steel samples, we measured the letter “Q” and the tail of the arrow. The measured values are 1.9916 mm and 1.5713 mm, compared to expected heights of 2 mm and 1.5 mm.

Measured repeatability.

To simulate mass production, we marked a series of elements (0.5 × 18 mm rectangles) on the plane in the X and Y directions, with a pitch of 10 mm. The positions were defined using the Coaxial Vision System (CVS)

[Learn more]. The marking was then repeated using the MULTI software option, setting the offset on the axes.

The maximum deviation from the nominal position was 15.5 µm over a 90 mm stroke.

Part Recognition. The combination of CVS and Pattern Matching [Learn More] ensures the precision and reliability required for mass production by automatically recognizing the part and detecting its position.

Durability: The marking remains intact; the material does not deteriorate

A medical marking must last as long as the device itself, without compromising the material. That is why we subjected it to two tests under particularly harsh conditions.

We have carried out:

• Boiling test ( Test G of ASTM A967/A967M-17), in which no sample developed rust: the laser did not compromise the surface’s passive layer.
• Sterilization test. The customer conducted an additional autoclave test on 24 samples to simulate wear from normal use. After several cycles, all markings remained easily legible, and no sample showed signs of rust.

Conclusions

The collaboration between Sisma and Sofab was essential to achieving a repeatable process that complies with medical regulations.

The Design Qualification (DQ) defined the acceptance criteria and the necessary documentation, and the Performance Qualification (PQ) demonstrated that BSP Pico fully meets and exceeds all requirements.

In summary, the project confirmed the key points requested by the client:

• Traceability: UDI marking generated from SQL database codes, compliant with FDA and EU MDR.
• Versatility: 5 product families on a single machine, 4 tested materials.
• Repeatability and precision: medical-grade blackening, minimal deviation in multiple placements.
• Legibility: excellent even after autoclave cycles.
• Automation: WH10 magazine with 10 trays, CVS, and Pattern Matching for unattended operation.

Sisma’s MODO Robot laser marking machine produces consistently high-quality markings on different areas of the same part and, thanks to the automatic gripper change, can also process different parts in the same cycle.

These are complex operations, but they become easy to program with the ROBO-PRO system.

What is ROBO-PRO?

ROBO-PRO is the simplified programming methodology developed by Sisma: the robot’s movements are automatically defined based on the configured laser processes.

What You Get Automatically with ROBO-PRO

• Automatic sequencing of robot movements, synchronized with laser processes.
• Automatic reordering of movements: if the order of the laser processes changes, the order of the robot movements changes accordingly.
• Exclusion of processes with a single click: the corresponding robot movements are automatically eliminated, optimizing cycle times.

No robotics experience required

With ROBO-PRO, programming is within the reach of any operator. There’s no need to generate paths or check for potential collisions: the software handles everything on its own, reducing setup time and the risk of errors.

In precision machining for third parties, operational flexibility and the reliability of welding systems are a strategic competitive advantage.

Meccanica Tecnica s.r.l. of Bastiglia (MO), a leading company in the precision engineering sector, needed to acquire high-performance industrial welding machines for the maintenance and repair of:

• Industrial Molds
• Bearings, shafts, and valve seats
• Turbine blades and high-stress components

The company’s primary goal was to cover the widest possible range in terms of the dimensions, weight, and geometries of hardened steel parts. To meet these manufacturing challenges, SISMA laser welding machines proved to be the winning technological choice.

The Advantages of Laser Welding

Laser welding offers significantly greater structural and operational benefits than traditional technologies, making it ideal for mold maintenance and micro-welding:

• Minimal heat input: During the deposition of the cladding material, the area affected by heat is extremely small.
• No deformation: deformation of the workpieces and metallurgical damage are either nonexistent or negligible.
• High mechanical strength: excellent structural integrity and high processing speed.
• Ultra-precise weld bead: ability to create millimeter-precise joints (down to a few tenths of a millimeter).
• Material versatility: excellent weldability on steel, aluminum, titanium, bronze, and copper alloys, as well as the joining of dissimilar materials (e.g., steel and copper).
• Cost-effectiveness: reduction in unit welding costs for high-volume production.

The SISMA Solution: Versatility and Software Automation

SISMA industrial laser welding machines are designed to ensure maximum accessibility even on the most complex geometries. They allow for easy operation in recesses, deep holes, sharp corners, edges, and grooves.

Using the intuitive software developed by SISMA, operators can create programmed welding paths that follow specific profiles and/or paths with regular shapes, such as circles or lines repeated at set intervals, etc.

Following a detailed analysis of the production processes and consultation with the SISMA engineering team, Meccanica Tecnica s.r.l. selected two fiber-based laser systems to cover the entire range of required machining operations:

SWA 450F

A fiber laser system specifically designed for mold repair and maintenance, ideal for depositing filler material on large surfaces and components.

SWT 450F

A high-precision laser welder, perfect for both general maintenance and precision micro-welding.

Why Choose Fiber Laser Technology Over Lamp-Based Lasers?

The integration of fiber-optic light sources into SISMA machines offers immediate operational benefits:

• Zero maintenance: drastic reduction in downtime and operating costs.
• Reduced focused spot: extremely small beam diameter, essential for corner joints and micro-welds.
• Higher average power: significant increase in deposition rate and welding speed on steel.

The SWA 450F and SWT 450F are machines that offer a high level of automation, but thanks to advanced visual inspection systems and an intuitive software interface, they are easy to use even for operators who are not highly specialized.

In dental implantology, traceability is not just a minor detail: it is what identifies a component and links it to the patient who receives it. B&B Dental, a Bologna-based company specializing in this sector, has entrusted SISMA with the development of a laser marking process for equipment and implants, serving both functional and traceability purposes. The markings must be imperceptible to the touch and remain perfectly legible over time, withstanding—in the case of equipment—repeated cycles of decontamination and autoclave sterilization.

The challenge: high contrast, no relief

Meeting both requirements involves removing very little material, while carefully adjusting the laser power, engraving speed, and spindle rotation. It is a delicate balance: a marking that is too shallow may fade over time, while one that is too deep can promote bacterial adhesion.

Technology: BSP, rotary-tilting spindle, and digital vision

The tests were conducted on a SISMA BSP machine equipped with a rotary-tilting spindle. The SLC3 software, interfaced with the CVS coaxial vision system, automatically identifies the area to be marked and precisely positions text, codes, and Data Matrix symbols even on complex geometries, such as the hexagonal head of a stump or the hollow interior of an implant.

BSP Pico, the SISMA machine used in tests with a 50-watt ultrashort-pulse laser source.

On this platform, two laser sources were compared: a 20 W MOPA and a 50 W Pico ultrashort-pulse laser. Here is a summary of the results obtained for the various components:

(2 bands + code)

The final result on the key shank with the ring nut: the Sisma mark and bands of continuous blackening, clearly legible and almost imperceptible to the touch.

The final result on the graduated key body: a graduated scale that is clearly legible and almost imperceptible to the touch.

The final result on the lanceolate milling cutter features bands and an alphanumeric code that are clearly legible and almost imperceptible to the touch.

The Real Test: Data Matrix Codes

A Data Matrix code must be marked on both the abutment and the implant to certify their mutual correspondence: a key requirement for the device’s traceability. On the abutment, a 1.16 × 1.16 mm code in 12×12 format is marked on the hexagon in approximately 10 seconds and is perfectly readable with a Cognex 8600 reader.

The Data Matrix code marked on the stump, as seen under a microscope.

The Extreme Challenge: 0.4 mm Inside the Implant

The only available surface on the device is the interior, which is difficult to reach, and the space for the code is limited to just 0.4 × 0.4 mm in a 10×10 format—a size that is beyond the capabilities of the MOPA laser. Only the 50 W Pico laser, thanks to its ultrashort pulses, was able to mark the code in about 10 seconds, with guaranteed readability under a microscope.

The 0.4 × 0.4 mm Data Matrix code marked inside the device, which can only be read using a Pico laser.

Why the Pico Won the Challenge

• High-contrast, long-lasting markings
• Excellent definition even on extremely small components
• Shorter processing times
• Repeatable production results

A Key Component of Regulatory Compliance: UDI Marking

SISMA’s software systems fully integrate with the SQL database to generate and manage UDI (Unique Device Identification) labeling, as required by FDA and EU MDR regulations, ensuring security, flexibility, repeatability, and traceability throughout the entire production process.

The B&B Dental–SISMA case study demonstrates how ultrashort-pulse laser technology, combined with coaxial digital vision and automated data management, is currently the most effective solution for marking small and complex dental devices.

When precision, efficiency, and reliability are essential, the right technology makes all the difference.

Dental laboratories face a growing challenge every day:

-Increasingly complex appliances
– Increasingly sophisticated materials
– Increasingly high quality standards
– Ever-shorter turnaround times

For this reason, Partners Dental Solutions, a U.S.-based orthodontic laboratory with over 140 specialized professionals, chose to integrate the SISMA LM-D manual laser welding system into its production process.

WHY DID THEY CHOOSE THE SISMA LM-D?

By integrating laser welding into its daily workflow, the laboratory can precisely handle:

• • Cobalt-chromium welds
• • Titanium orthodontic appliances
• • Complex and custom devices

According to Djamil Abiyev, President & CEO of Partners Dental Solutions: “SISMA technology has become a fundamental component of our production process, enabling us to perform precise and consistent welds on a wide range of orthodontic applications.”

LM-D for dental applications

CONCRETE BENEFITS FOR LABORATORIES:

– Greater welding precision
– Reproducible and reliable results
– Reduction in post-processing
– More efficient workflow
– Greater production control

To meet specific production needs, we developed a configuration of SWT Open 450 F with dual spindles, ideal for welding coaxial cylindrical elements.

This solution allows the process to be significantly improved in several respects:

• Superior accuracy: the coupling of components is extremely accurate, ensuring perfect coaxiality
• Time optimization: eliminates the need to position and point pieces separately
• Process simplification: no more need to use tailstocks
• Increased production capacity: through-hole spindles allow long components to be machined.

An additional strength is the versatility of the configuration: the second spindle can be easily excluded, allowing a return to single-spindle tilting mode.

This customization finds application in areas where precision is not an option but a must:

• production of thermocouples
• realization of sensors
• medical components

Areas where repeatability, quality and process control are crucial to the end result.

Watch the video of the processing.