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Corin Gets 510(k) Clearance for Cross-Linked Polyethylene Liners, Large Diameter Heads
Source: Device Daily Bulletin 5 July 2011
Corin has received a 510(k) clearance for its polyethylene liners and large diameter CoCr and BIOLOX Delta Ceramic heads for its Trinity acetabular system. The larger bearing sizes in the Trinity system are compatible with Corin’s MiniHip and MetaFix hip stems. The MiniHip is a short, neck-preserving stem design geared toward active patients.
Significant step forward for Corin in access to the world’s largest orthopaedic market.
29 June 2011 – From Corin Website http://www.coringroup.com/news.php?o=119
Corin launches new hip portfolio in the world’s largest orthopaedic market following FDA 510(k) clearance for Trinity HXLPE bearings and large diameter CoCr and BIOLOX® Delta Ceramic heads (up to 40mm).
Earlier this month, Corin received 510(k) clearance from the FDA for highly cross-linked polyethylene liners and large diameter CoCr & BIOLOX® Delta Ceramic heads for its Trinity acetabular system enabling it to commence sales of these products to US customers, including its new US distribution partner Mako Surgical Corporation.
The move marks a significant step forward in the launch of Corin’s hip portfolio in the US and enables the company to offer a range of high performance bearing solutions within a versatile Continuum of Hip Care to surgeons across the country. Corin’s Continuum of Hip Care offers the ability to choose the right implant for a broad spectrum of patient indications with a range of choices that focus on bone conservation, hip stability, fixation and wear. Today’s active patient population are placing greater demands on their hip replacements and the ability to address individual surgeon and patient requirements is a fundamental part of a modern day hip portfolio.
The larger bearing sizes in the Trinity system are compatible with Corin’s MiniHip and MetaFix hip stems. MiniHip is a new short, neck preserving, stem design which encompasses next generation cementless technology and provides an advanced bone conserving solution for active patients. MetaFix is a cementless total hip replacement system founded on a proven, world-leading stem philosophy, with a broad range of sizes and neck offsets. Together with the Trinity advanced cup system and large diameter CoCr and Ceramic heads, these products provide a high degree of flexibility, allowing surgeons to choose the right solution for individual patient needs.
Surgeries have been completed in a number of key institutions across the country and feedback has been extremely positive. Dr Ranawat of the Hospital for Special Surgery (New York) commented “I recently performed my first THR using the Corin hip system. I was impressed with its design features and instrumentation. It has the versatility of bearing choices to meet even the most demanding patients.”
Russell Mably, Corin’s Managing Director of Commercial Operations, said “We are delighted to have obtained approval for a number of our key products in the US. This, along with our 5 year distribution agreement with MAKO Surgical, marks a significant step forward in our strategy, and underlines our commitment to developing a presence in the world’s largest orthopaedic market.”
Andy Sutcliffe Corin’s Group Marketing Director added, “We have invested heavily in building a strong marketing infrastructure within the US. We have established a number of key Centers of Excellence to ensure that we can train and support the surgeon community effectively, and are excited about our future plans for our Continuum of Hip Care portfolio in the US market.”
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