SAN DANIELE DEL FRIULI, Italy, Aug. 28, 2018 /CNW/ - LimaCorporate is proud to announce that another milestone has been reached following the SMR Reverse ODEP Ratings in March 2018. Physica ZUK has been awarded by the Orthopaedic Data Evaluation Panel (ODEP) in the UK with the following two ratings (latest ODEP ratings can be found at www.odep.org.uk):
- 10A ODEP Rating - Physica ZUK with a Metal Back Tibial Baseplate component;
- 7A ODEP Rating - Physica ZUK with an all-Polyethylene Tibial Baseplate component.
The ODEP was set up in the United Kingdom in 2002 and provides an ongoing assessment of arthroplasty implants to benchmark Hip, Knee and Shoulder prostheses, providing a standard rating for their survivorship and data submission quality.
Unicondylar Knee Replacement ratings are awarded according to the strength of the evidence and the quality of the data provided. The main criteria are the survivorship of the implants, the number of patients and the length of follow-up. Many countries outside the United Kingdom now use these ratings to assist in their approval of products into the market place. ODEP ratings provide a simple, independently verified assessment of the performance of an implant, assessed against best clinical practice guidelines.
LimaCorporate is proud to remark that Physica ZUK was awarded an ODEP 10A rating in 2018 and it is currently one of the only unicondylar knee replacement prostheses to be awarded with a 10A benchmark. The awarding of the ODEP 10A rating corroborates the evidence provided by several international orthopedic registries, assessing that Physica ZUK is one of the best performing unicompartmental knee prostheses available on the market. ZUK was acquired by LimaCorporate from Zimmer Biomet in 2015 and then was denominated Physica ZUK as LimaCorporate became the legal manufacturer of this device within the European Economic Area, Switzerland and Japan. In compliance with EU Antitrust Authorities and pursuant the Asset Purchase Agreement executed with Zimmer Holdings Inc, LimaCorporate acquired, "Intellectual property rights and know-how, transfer of licences, permits and authorizations, transfer of access to CE marks, customer contracts, leases, commitments, orders and records". Therefore ZUK & Physica ZUK are identical prostheses, implant combination is allowed, and the historical clinical data referred to ZUK is also applicable to Physica ZUK.
"I have been a ZUK user for the past nine years. My patients' experience has been extremely positive and as a surgeon carrying out over 100 unicompartmental knee replacements a year, I am pleased with the new ODEP rating for the Physica ZUK. The surgeon-friendly instrumentation and the unrivalled long-term survival figures make it easy for me to continue to offer it to my patients," said Mr. Guido Geutjens, Derby Hospital, UK.
To reinforce the strong position held by Physica ZUK, during the second half of 2018 new Physica ZUK instruments will be launched in Europe, Switzerland and Japan. Physica ZUK also provides patient-specific cutting guides and the unique OrthAlign® hand-held surgical navigation technology for precise alignment and positioning.
"The achievement of the 10A ODEP rating for the Physica ZUK is yet another recognition for LimaCorporate, following the 10A ODEP rating received for the SMR Reverse in March, demonstrating our commitment to provide reliable and high-performing implants to Orthopaedic surgeons. On behalf of all of LimaCorporate, I would like to thank the surgeon community that believed in Physica ZUK to help achieve this ODEP rating and the excellent registry results", said Luigi Ferrari, Chief Executive Officer of LimaCorporate.
LimaCorporate is a global medical device company providing reconstructive and custom-made Orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. LimaCorporate's product range includes large joint revision and primary implants and complete extremities solutions including fixation.
SOURCE Limacorporate S.p.A.
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