INDUSTRIAL KNOW-HOW & ORTHOPAEDIC SURGERY.

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1 INDUSTRIAL KNOW-HOW & ORTHOPAEDIC SURGERY

2 A new century for groupe lépine : As a French company steeped in the business of orthopaedics, we are ready to take on new challenges in the wake of our tercentenary celebration. As a preferred partner of the medical profession both in France and abroad, we are continuously innovating and improving our medical devices to facilitate surgical procedures and patient comfort. We are committed to providing the highest quality products, in full compliance with current and future regulatory requirements. Full involvement of all the players in the process linking our know-how, industrial mastery, deep understanding of hospital budgets and careful listening to the medical profession, in combination with on-going clinical evaluation of our products, helps to ensure the perfect match between groupe lépine s policies and the medical field, and to consolidate its worldwide reputation. groupe lépine s goal is to become, tomorrow, your indispensable partner. Patrick PFAIFER, President Designed & manufactured 4 sales subsidiaries in France International coverage 100 % More than 200,000 products manufactured annually including sterile implants 180,000 2

3 A 300-YEAR EXPERIENCE We are proud of our history as a French company continuously involved in the design and manufacture of orthopaedic implants. The relevance of our knowledge acquired through experience has withstood the test of time. French industrial know-how groupe lépine is a French company developing and manufacturing all its products in the Lyon area, thereby capitalising on our legitimacy in orthopaedic surgery. Serving the orthopaedic profession Well-established, mutually beneficial collaborations with our partners allow us to develop new joint implant ranges being more reliable and more effective. In compliance with current and future regulatory requirements Our long history has provided us with a deep understanding of the constraints, obligations and responsibilities that come when involved in the healthcare field. This knowledge is woven into the fabric of our company s culture and expresses itself through our orthopaedic surgery expertise. In-house mastery In an era where the production and sometimes even the design of implants is often sub-contracted or relocated abroad, groupe lépine has decided to keep its production activities in France and perform all these steps in-house. As a consequence, the industrial team now consists of a design office, engineers focused on methodology and specialized quality controllers m 2 of office space and industrial buildings Already 150,000 hip prostheses implanted Nearly 25 missions serving the orthopaedic industry 3

4 FROM EXPERTISE TO MASTERY Design always taking into account joint biomechanics Understanding of materials resulting reliable, well-matched solutions Mastery of processes having added value over many years 4

5 Hip Comprehensive range of products for all indications. Cargos Cup / Pavi Stem Quattro Cup / Targos Stem Knee Range of unicompartmental, tricompartmental and revision prostheses. New Wave Endurance Osteosynthesis Upper limbs joints Trapeziometacarpal joint prosthesis and fixation of distal radius fractures. Threaded anchors Memofix Memosorb Visiofix Maïa Safety and Innovation By using our know-how and understanding of the market, groupe lépine has been able to develop reliable and effective implants with a significant clinical follow-up. We have also come up with new solutions to meet the requirements of personalised, cutting-edge treatment of various joint conditions. 5

6 FROM PERFORMANCE TO EXCELLENCE Company Certifications Well in advance of regulatory requirements, groupe lépine sought certification for all of its design, manufacturing, control and distribution activities based on the ISO 9001 Quality Assurance model. Adopting the new NF EN ISO requirements was a natural progression for us in As a result of this constant anticipation, a commitment to Quality has spread through the entire company. Mechanical validation groupe lépine performs mechanical validation tests on its implants. Testing protocols and instruments were specifically developed for this purpose. We have been collaborating closely with AFNOR (French national organisation for standardisation) during discussions surrounding national and international regulatory requirements for: Materials for surgical implants Joint prostheses Cleaning of orthopaedic implants Clinical follow-up A team of doctors, epidemiologists, pharmacists, and regulatory and clinical affairs managers work together to: Monitor recent scientific studies to provide our Research & Development and Marketing Departments with the most advanced orthopaedic knowledge. Collect clinical data and write the reports needed to obtain the CE marking. Provide the necessary post-market clinical follow-up in the context of medical device vigilance and regulatory evaluation principles. 6

7 5 good reasons to choose groupe lépine if you are A patient 1 Be confident that your surgeon has been well-informed about the features of the prosthesis by its manufacturer. 2 Be certain that the prosthesis being implanted has been designed to facilitate your functional recovery. 3 Be reassured by the large number of patients who have already been successfully treated with the same prosthesis. 4 Be certain that the implant s materials and all the manufacturing steps have been controlled and validated meticulously. 5 Benefit from a manufacturer who knows the importance of integrating pharmacists and doctors into its team. A surgeon 1 Collaborate with a company who listens to your expectations. 2 Obtain reliable implants which will not compromise the quality of your surgical procedure. 3 Use simple instrumentation which has been designed to make your surgical procedure more accurate. 4 Benefit from responsive customer service (product information, fast and accurate deliveries, etc.) 5 Participate to the evaluation of clinical results on case series both individually and collectively. A distributor 1 Be certain that the implant s price/quality ratio is appropriate for your market. 2 Be reassured on the availability of world-class orthopaedic products. 3 Collaborate with a European manufacturer who is renowned for its industrial know-how. 4 Benefit from a marketing support to implement activities that reinforce groupe lépine s brand image. 5 Enjoy a long-term collaboration with a partner who knows how to adapt to the specific needs of each market. 7

8 08002 A / V4 / lépine Algérie 9 rue philosophe Tabrizi Les sources Bir Mourad Rais - ALGER lepine-algerie@groupe-lepine.com lépine Italia Via Cassanese, Segrate (Milano) lepine-italia@groupe-lepine.com lépine Ibérica C/J.J. Tadeo Murguía N. 3-5 BAJO IRÚN (GUIPÚZCOA) lepine-iberica@groupe-lepine.com lépine Maroc 79 avenue IBN SINA RABAT - AGDAL lepine-maroc@groupe-lepine.com 175 rue Jacquard - CS Genay Cedex - FRANCE Tél. +33 (0) Fax +33 (0)