Manufacture of an Implant
Design and Prototyping

The design and prototyping of all groupe lépine implants is carried out in Genay, at the headquarters, by a validated and efficient R & D Department.

Prototyping, which aims to validate the manufacturing plans for implants, is also performed in-house using 3D printers.

Forge

groupe lépine has its own forge based in Orthez. This ancestral technique provides hot or cold forming of a metal bar.

Foundry

As the first stage in manufacturing complex geometrical implants, the foundry ensures a maximum degree of precision. The implants are made by casting the selected alloy in silica moulds.

It is the only manufacturing process carried out abroad, within the German subsidiary located in Stade.

Machining

Integrated into the production site of Genay, the machining involves a family of techniques for part manufacturing by chip removal.The machining aims to give the implant its final shape.

Coating

In order to improve the osteointegration of some implants, their surface is coated with hydroxyapatite.

It is injected in powder form in a high temperature gas and projected on the part to be coated.

Ceramics

Some heads and inserts are made of ceramic. Their forming requires a particular well-controlled technique by our Genay factory. The main material composed of various alumina-based oxides is compacted and formed by dry pressing before being heated to a very high temperature. Follow the steps of precision mechanical machining by grinding and polishing.

Mechanical and Clinical Validations

All implants designed by groupe lépine are compliant with the standards of mechanical validations and are often tested beyond these mandatory requirements. The company made the choice to internalise all of these validation protocols.

A Regulatory Affairs team is in charge of drafting clinical data required for obtaining the CE markings. It also ensures post-marketing scientific and clinical surveillance.

Other Trades of Ours

Splints

The Lépine Soft splints have been developed over more than 25 years in our Lyon and Roanne workshops. They combine orthopaedic requirements, industry trades and technical nature of the industry to ensure its customers of optimal quality for each of the certified CE-marked Lépine Soft splints.

Tissue Bank

TBF Tissue Bank, ISO 9001 certified, offers a complete range of bone substitutes to meet the clinical needs of orthopaedic, spinal, neuro- or trauma surgeons. The use of bone grafts of human origin, mineralised and spongious, from living donors, processed by a highly-secure and proven process, offers an ideal solution for bone reconstruction.

Plastics

The ICB structure, industrial subsidiary of groupe lépine located on the site in Genay is specialised in the injection of medical polymers. This process allows for the serial production of single-use instrumentation and resorbable implants.

Memory Shape Alloy

In 1998, groupe lépine decided to internalise the manufacture of its osteosynthesis staples as well as its Kirschner wires by creating AMF (Alliage à Mémoire de Forme), one of its first industrial subsidiaries located in Lury-sur-Arnon in France.
The company, which today has 15 employees, has also become over time a prototype manufacturing and mechanical testing platform for the Group.