Fully-Automated spinal screws engraving, assembling and packing

Market

Implantable Medical Device for Spine Fusion Surgery

Spinal pedical screws

FDA Device Class # 2 Customer Spinal products are distributed worldwide

The market of spinal implants is primarily driven by some of the advancements in spine surgery technologies and the increasing adoption of minimally invasive spine surgeries Customer final products are distributed worldwide


Customer

International Group specialized in Medical Devices

The machine is installed in a unit dedicated to spinal implants design and production

The facility produces à total of around 1.2 million implants per year

The delivered machine engraves, assemble and pack around 600 thousand implants per year

The customer acquired the machine to:

  • Replace the existing manual production workshop
  • Increase the facility capacity
  • Improve and strengthen the processes repeatability
  • Implement a more efficient traceability system directly linked to its ERP
  • Comply with coming new rules

Project main requests and constraints

Very high batches sizes variability > from 20 up to 2 000

17 products variants in 7 "families"

  • Smaller parts = Ø   5.95 x H 2.52 mm
  • Bigger parts   = Ø 11.30 x H 7.78 mm

Fast, simple and secure variants changes < 10 minutes

User-friendly interface for quick recipes changes

Limited floor space in an existing Cleanroom


AS.MED main requirements

Spinal parts:

  • Feeding > from bulk with bowl-feeders,
  • Controlling > by vision with measurement accuracy ≤ ±25 µm
  • Handling,
  • Orienting > by vison,
  • Laser-engraving > with accuracy ≤ ±50 µm
  • Engraving position, accuracy and quality control > by vision,
  • Assembling by screwing > with position, force and torque control

Assembled spinal implants

Final control > by vision,

Handling,

Blistering:

  • Deposition in blister with identification (UDI)
  • Label printing and placing (on the blister)
  • Insertion of Instruction For Use (IFU) (with control)
  • Blister sealing

Unloading in boxes


For more information, please CONTACT US

Spinal screw