PEEK and Titanium Spinal Spacer System

Velosity was challenged to design, develop and qualify a complete manufacturing process for a thoracic spinal implant system that incorporates the molding of two additive manufactured titanium plates and consists of 75 size variations within five design families.

Case Studies

PEEK and Titanium Spinal Spacer System

Solution Profile

Velosity was challenged by a long-time customer to design, develop and qualify a complete manufacturing process for a thoracic spinal implant system that incorporates the molding of two additive manufactured titanium plates and consists of 75 size variations within five design families.

The customer also had an aggressive schedule of six months to design and fabricate all tooling and fixturing and have all of the aforementioned processes qualified and have all part sizes ready for DVT testing.

Solving the Manufacturing Challenge

The new manufacturing process needed to include:

  • Machining to size 75 variations
  • Descaling and passivation of the titanium plates
  • Insert molding using a high-heat implantable material (PEEK)
  • Post-molding thread machining operation
  • Annealing
  • Laser engraving
  • Cleaning & packaging

For Velosity, it all starts with early involvement with the project.

Our teams started immediately collaborating on the design for manufacturability. All tools and fixtures were designed and fabricated in-house. All molds were built in parallel. Two master bases were built to house the 75 different sizes and allow flexibility for process development.

Next the team developed insert machining, insert molding, and post-molding machining processes as each tool was completed to keep the project on schedule. Precise planning and coordination for 24 / 7 manufacturing to meet the extremely aggressive schedule. Our team worked through the holidays to ensure the project was completed on time.

To eliminate redundant inspections, first article and qualification activities took place at Velosity with the customer on-site. The qualification process focused on an elaborate analysis of the smallest and largest sized components in each of five design families.  From there, Velosity proved the equivalency on the other sizes.

 

Velosity provided these results to the customer:

  • Production quantities for each part (100-250 pieces per size) were ready to ship upon approval.
  • All schedules and expectations were met and the customer was extremely satisfied.
  • Our successful completion of this project led to the later award of another large project for an implantable lumbar product.