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PLUS Orthopedics USA, Inc. Announces FDA Clearance and Market Availability Of Next-Generation Computer-Assisted Orthopedic Surgery System


2/15/2007 10:39:07 AM

SAN DIEGO, CA -- (MARKET WIRE) -- February 15, 2007 -- 2007 AAOS Annual Meeting booth # 1642 -- PLUS Orthopedics USA, Inc. today announced U.S. Food and Drug Administration 510(k) clearance and market availability for the next-generation PiGalileo™ computer-assisted surgery system. With this FDA clearance, Plus Orthopedics is now able to offer a wide range of surgical solutions for knee replacement procedures, including minimally invasive surgery, ligament balancing options, and enhanced functionality of the company's flagship computer-assisted surgery and robotic instrument positioning technologies. The PiGalileo™ Computer-Assisted Orthopedic Surgery System has been used for more than 15,000 joint replacement procedures internationally since 1999.

Medical literature has shown that two of the most common causes of joint implant failure are implant misalignment and ligament instability, with a misalignment of only 3-degrees being strongly correlated to excessive wear and tear on the joint and implant failure over time. With the introduction of these new solutions, surgeons are now able to reduce the potential for misalignment, address stability concerns, and do so with a minimally invasive procedure that aims to shorten recovery time for the patient.

"The market availability of these new navigation modules represents a significant advancement for the field of total joint replacement surgery," said Craig Grabell, CEO of Plus Orthopedics, USA. "In addition to our computer-assisted robotic instrument positioning technology, we can now provide solutions for minimally invasive surgery and ligament balancing, which to our knowledge makes us the only company with such a wide range of options for total knee replacement available today to the U.S. market."

The PiGalileo™ Computer-Assisted Orthopedic Surgery System from PLUS Orthopedics combines advanced Computer-Assisted Surgery and robotic instrument positioning technologies to assist the surgeon in total knee replacement procedures. Surgeries done with PiGalileo™ are still performed by a surgeon, with cut guides that can be precisely adjusted with 6-degrees of freedom. By rigidly holding the femoral cut guide, the system eliminates the need for pins which are a significant source of alignment deviation. Moreover, the technology provides valuable intra-operative feedback to the surgeon to help improve precision and ligament balance, thereby potentially leading to better balance, implant alignment, and positioning.

The PiGalileo™ Computer-Assisted Orthopedic Surgery System can be seen at the 2007 AAOS Annual Meeting (February 14-16) at booth # 1642.

About PLUS Orthopedics USA, Inc.

PLUS Orthopedics USA, Inc. is a wholly owned subsidiary of PLUS Orthopedics Holding, AG, a manufacturer of implant systems for the hip, knee and shoulder joints, as well as products for the treatment of orthopedic trauma, since 1997. PLUS Orthopedics USA, Inc., headquartered in San Diego, California, is now bringing these products to patients across the U.S. with a commitment to offering our customers high quality products and services with proven results. For more information visit the company's web site at www.plusortho.com.

MC00276v01

Contacts:

PLUS Orthopedics: Tim Frandsen Director of Navigation Systems (858) 518-2279 Email Contact www.plusortho.com

SOURCE: Plus Orthopedics, USA

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