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United Orthopedic Corporation Announces First Patient Enrollment in Study of U2 Knee™ System

May 23, 2017

UNITED ORTHOPEDIC CORPORATION ANNOUNCES FIRST PATIENT ENROLLMENT IN STUDY OF U2 KNEE™ SYSTEM

Study to Evaluate Clinical Performance and Safety of the System in Primary Total Knee Arthroplasty

IRVINE, Calif., May 23, 2017 – United Orthopedic Corporation (UOC), a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments, today announced the launch of a primary total knee arthroplasty (TKA) trial. Entitled “Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System – ‘U Propel Study’,” the trial recently enrolled its first patient. This prospective, single arm, multi-center, post-market study will evaluate the short- and long-term clinical performance, and implant survivorship of the commercially available U2 Knee™ System in subjects receiving primary TKA.

“We were extremely confident with the execution and success of the first U2 Knee System replacement,” said David Cashen, MD, principal study investigator and practicing orthopedic surgeon at Coastal Orthopedics in Bradenton, Fla. “One day after surgery our patient is ambulating independently, performing a straight leg raise and confident to return home with only mild discomfort. We look forward to monitoring her recovery through our research.”

The U-Propel study will enroll up to 200 patients. Patients will participate in baseline, pre-discharge, six-week, three, six and 12-month, as well as annual follow-up visits for up to five years. The study’s primary endpoint is implant survivorship. The secondary endpoints are Knee Society Score; radiographic success; subject satisfaction; KOOS, Jr.; EQ-5D and operative characteristics. The expected duration of the study is seven years.

“For more than two decades, our company has been engaged in helping orthopedic surgeons deliver high-quality care to their patients, providing them with innovative products designed to improve patient health and satisfaction,” said Calvin Lin, President of United Orthopedic Corporation USA. “The U-Propel study underscores our continued commitment to orthopedic care, building upon our foundation of research that demonstrates the value of our solutions.”

Outcomes from the U-Propel study will be analyzed and published in three phases as follows: after all enrolled patients have completed their six-week follow-up; at the two-year follow-up mark; and at the conclusion of the study. In addition to Dr. Cashen and the team of surgeons at Coastal Orthopedics, George Markovich, MD, is also an orthopedic surgeon and study investigator. Dr. Markovich is from the Institute for Orthopaedic Surgery and Sports Medicine in Fort Myers, Fla.

Osteoarthritis is a common disease of the aging demographic and a leading cause of disability, with the incidence of knee osteoarthritis rising with the increasing average age of the general population.1 Approximately 10 percent of people aged over 55 years have painful disabling knee osteoarthritis, of whom one quarter are severely disabled.1 TKA is one of the treatment options available to sufferers of knee osteoarthritis.

For more information about the U-Propel study, visit: https://clinicaltrials.gov/ct2/show/study/NCT03060057

UOC is actively recruiting qualified surgeons and their institutions who would like to participate in this post-market study. Please contact Mindy Carlson, Director of Clinical Research, at mindy.carlson@uocusa.com, or 612-562-0060, to inquire.

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About United Orthopedic Corporation
United Orthopedic Corporation (UOC) is a leading international designer, manufacturer, and distributor of innovative, regulatory compliant orthopedic implants and instrument sets used by surgeons around the globe. UOC’s offering includes a flexible range of clinically proven solutions used to perform total hip/knee replacements and revisions, plus clinical education, service and support for surgeons and hospital staff. UOC operates Quality Management Systems (QMS) that comply with ISO 9001/13485, FDA, and CE requirements. For more information about United Orthopedic Corporation, visit www.uocusa.com.

Media Contact:
Tiffany Lin
tiffany.lin@uocusa.com
Tel: +1 949-328-3366

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1 Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian Journal of Internal Medicine. 2011;2(2):205-212.

United Orthopedic Corporation Receives U.S. FDA Clearance for Company's Polyethylene Knee Insert

April 12, 2017

UNITED ORTHOPEDIC CORPORATION RECEIVES U.S. FDA CLEARANCE FOR COMPANY’S POLYETHYLENE KNEE INSERT

E-XPE™ Designed to Provide Wear Resistance With Reduced Risk of Oxidation

IRVINE, Calif., April 12, 2017 – United Orthopedic Corporation (UOC), a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments, today announced that the U.S. Food and Drug Administration (FDA) cleared its E-XPE™ polyethylene knee insert. The knee insert is designed to provide patients with knee replacements with reduced risk of oxidation.1

“Clearance of our E-XPE™ polyethylene knee insert represents an important milestone in our knee portfolio,” said Calvin Lin, President of United Orthopedic Corporation USA. “Oxidation continues to be a concern for surgeons. The E-XPE™ polyethylene is resistant to oxidation and performs extremely well with respect to abrasive wear resistance.”

The E-XPE™ is the new generation of highly cross-linked polyethylene blended with 0.1 percent (w/w) vitamin E to enhance wear resistance without compromising oxidative stability and mechanical properties.

UOC’s vertically integrated manufacturing process is unique, enabling the company to control the production cycle of their implants, from initial design to distribution in each of its manufacturing facilities. By doing so, UOC is capable of ensuring a stable, quality product supply and a remarkable level of customization to meet the needs of patients.

More than 600,000 knee replacements are performed each year in the United States.2

About United Orthopedic Corporation
United Orthopedic Corporation (UOC) is a leading international designer, manufacturer, and distributor of innovative, regulatory compliant orthopedic implants and instrument sets used by surgeons around the globe. UOC’s offering includes a flexible range of clinically proven solutions used to perform total hip/knee replacements and revisions, plus clinical education, service and support for surgeons and hospital staff. UOC operates Quality Management Systems (QMS) that comply with ISO 9001/13485, FDA, and CE requirements. For more information about United Orthopedic Corporation, visit www.uocusa.com.

Media Contact
Tiffany Lin
United Orthopedic Corporation
Tel: +1 949-328-3366
Email: Tiffany.Lin@uocusa.com

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1 Bellare, A. et al. Journal of Applied Polymer Science (2016). Oxidation Resistance and Abrasive Wear Resistance of Vitamin E Stabilized Radiation Crosslinked Ultra-High Molecular Weight Polyethylene, DOI:10.1002/APP.44125.
2 American Academy of Orthopedic Surgeons website. Beyond Surgery Day: The Full Impact of Knee Replacement. Accessed April 10, 2017 from: http://www.anationinmotion.org/value/knee.

United Orthopedic Corporation (UOC) Donates Orthopedic Replacement Systems to Hospital in China

July 5, 2016

United Orthopedic Corporation (UOC) Donates Orthopedic Replacement Systems to Hospital in China

Company Works With Atlanta-Area Surgeon to Provide Orthopedic Support to Underprivileged Community in Hefei

IRVINE, Calif., July 5, 2016 -- United Orthopedic Corporation (UOC), a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments, today announced the company has donated total hip and knee replacements to a hospital in Hefei China, 300 miles inland from Shanghai.

Freddy Achecar Jr., MD, medical director for the WellStar Douglas Hospital Center for Joint Replacement in Douglasville, Georgia, donated his services to help patients with limited income needing knee or hip replacement surgery.

“We were thrilled to have had the opportunity to give back to communities in need and work with a leading orthopedic surgeon,” said Calvin Lin, President of UOC USA, a subsidiary of UOC located in Irvine, CA. “There are villages, towns and cities in China located in remote areas, limiting patients’ and healthcare professionals’ access to optimal treatment. Working with Dr. Achecar to improve the lives of these patients has been wonderful.”

The donation was inspired by Dr. Achecar and his 17-year-old son Adam. As part of his Eagle Scout project, Adam wanted to incorporate his father’s work of restoring movement to patients who suffered from orthopedic conditions, and make treatment available to individuals who did not otherwise have access to such care.

Dr. Achecar liked his son’s idea and, as a result, reached out to his hospital’s supplier of orthopedic implants, UOC. UOC recommended that the doctor travel to the city of Hefei to help treat patients who had been historically underserved. UOC agreed to donate the necessary medical devices. The program was designed to provide patients with disabilities and the elderly, as well as low-income households, with joint replacement treatment they may otherwise not have had access to on their own.

Dr. Achecar spent a week performing seven joint replacements: five hip replacements and two knee replacements. His first patient was a 72-year old chicken farmer who had been bedridden as a result of his arthritis and needed a hip replacement. To his amazement, the very next day he felt no pain and went home to tell his wife. As a thank you, he returned to the hospital with a basket of eggs fresh from his farm, saying “this is our gift to you.”

“We are very grateful to be given this opportunity to make a real difference in the lives of these patients by helping them get the care they need for their joint pain,” said Dr. Achecar. “It has been an amazing journey and experience. We are thankful to UOC and their team for their commitment to patient care.”

UOC’s unique manufacturing process enables the company to control the production cycle of their implants, from initial design to distribution in each of its manufacturing facilities. By doing so, UOC is capable of ensuring the highest quality standards, a stable product supply, and a remarkable level of customization to meet the specific needs of each patient.

About United Orthopedic Corporation
United Orthopedic Corporation (UOC) is a leading international designer, manufacturer, and distributor of innovative, regulatory compliant orthopedic implants and instrument sets used by surgeons around the globe. UOC’s offering includes a flexible range of clinically proven solutions used to perform total hip/knee replacements and revisions, plus clinical education, service and support for surgeons and hospital staff. UOC operates Quality Management Systems (QMS) that comply with ISO 9001/13485, FDA, and CE requirements. For more information about United Orthopedic Corporation, visit www.uocusa.com.

Media Contact
Tiffany Lin
United Orthopedic Corporation
Tel: +1 949-328-3366
Email: Tiffany.Lin@uocusa.com

United Orthopedic Corporation Announces Enrollment of First U.S. Patient in Hip Replacement System Follow-Up Study

February 23, 2016

United Orthopedic Corporation Announces Enrollment of First U.S. Patient in
Hip Replacement System Follow-Up Study

Company Initiates U.S. Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem for Patients Who Require Primary Total Hip Arthroplasty

IRVINE, Calif., February 23, 2016 -- United Orthopedic Corporation (UOC), a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments, today announced the start of patient enrollment in a follow-up study in the U.S. of the commercially available U-Motion II+ Acetabular System and UTF Reduced Stem in patients receiving primary total hip arthroplasty (THA). The prospective, single arm, multi-center, post-approval study is designed to evaluate the short and long-term clinical performance of the devices, which are designed to improve hip flexion, reduce the risk of joint dislocation and allow for minimal bone removal during THA procedures.

“Despite numerous advances in hip replacement technology, issues such as postoperative dislocation, bearing wear and insufficient range of motion remain challenging problems, especially for younger, more active individuals,” said Kurtis Biggs, DO, founder of the Joint Replacement Institute in Naples, Florida. “The U-Motion II+ Acetabular System and UTF Reduced Stem are designed to address these issues by using enhanced implant materials, which allow for improved hip flexion and less risk of joint dislocation. We plan to investigate the clinical performance of the devices to further establish its benefit for patients seeking relief of hip pain or improved hip function.”

Dr. Biggs implanted the first U-Motion II+ Acetabular System and UTF Reduced Stem on a patient enrolled in the study on January 20, 2016 using the direct anterior approach, a minimally invasive, tissue-sparing technique that allows for quicker recovery and improved outcomes for patients. UOC plans to enroll up to 200 patients at a maximum of five sites in the U.S.

“This is an important milestone for United Orthopedic Corporation as we continue to establish our presence in the United States and provide life-changing technologies to address an unmet need in patients seeking a long-term solution for severe hip pain,” said Calvin Lin, President of UOC USA, a subsidiary of UOC located in Irvine, CA. “For over two decades, UOC has offered meaningful orthopedic solutions to practitioners and institutions that improve patient care.”

The primary objectives of the study include operative success, hip function at two-year follow up as measured by the Harris Hip Score (HHS) and device survivorship. Patients will be evaluated at predetermined intervals: baseline, procedure/discharge and six weeks, three months, six months, 12 months, and 24 months post treatment for primary analysis and annually up to five years for device survivorship. The estimated study duration from first enrollment through completion of the final report is expected to be approximately seven years.

The U-Motion II+ Acetabular System utilizes a unique coating technology intended to achieve a greater surface roughness of the implant. This allows for better initial stability and has been shown to reduce micromotion, both of which contribute to the long term fixation of the implant. , The UTF Reduced Stem, forged from titanium alloy, is a wedge-shaped stem that facilitates optimal placement and fit in femora of varying disphyseal and metaphyseal widths. It comes in 14 sizes, with standard and high offset options, and key sizes (ranging from 3 to 8) with 1mm increments. The stem features optimized neck geometry, which contributes to increased range of motion and decreased cup-neck impingement.

According to the Centers for Disease Control and Prevention’s National Center for Health Statistics, the number of total hip replacement surgeries among inpatients aged 45 and over more than doubled from 2000 to 2010, from 138,700 in 2000 to 310,800 in 2010.The percentage increase in the number of total hip replacements among inpatients aged 45 and over by age ranged from 92 percent for those 75 and over to 205 percent for those aged 45–54. UOC is dedicated to providing advanced solutions for joint treatment as the U.S. population ages and demand increases for improved technologies and procedures.

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About United Orthopedic Corporation
United Orthopedic Corporation (UOC) is a leading international designer, manufacturer, and distributor of innovative, regulatory compliant orthopedic implants and instrument sets used by surgeons around the globe. Our offering includes a flexible range of clinically proven solutions used to perform total hip/knee replacements and revisions, plus clinical education, service and support for surgeons and hospital staff. UOC operates Quality Management Systems (QMS) that comply with ISO 9001/13485, FDA, and CE requirements. For more information about United Orthopedic Corporation, visit www.uocusa.com.

Media Contact:
Tiffany Lin
tiffany.lin@uocusa.com
Tel: +1 949-328-3366

  1. Moskal J, Capps S, Scanelli J. Anterior muscle sparing approach for total hip arthroplasty. World J Orthop. 2013 Jan 18; 4(1): 12–18. Published online 2013 Jan 18. doi: 10.5312/wjo.v4.i1.12
  2. Jasty M et al. In vivo skeletal responses to porous-surfaced implants subjected to small induced motions. J Bone Joint Surg Am. 1997 May;79(5):707-14.
  3. Feighan JE et al. The influence of surface-blasting on the incorporation of titanium-alloy implants in a rabbit intramedullary model. J Bone Joint Surg Am. 1995 Sep;77(9):1380-95.
  4. Wolford ML, Palso K, Bercovitz A. Hospitalization for total hip replacement among inpatients aged 45 and over: United States, 2000–2010. NCHS data brief, no 186. Hyattsville, MD: National Center for Health Statistics. 2015. Available from: http://www.cdc.gov/nchs/data/databriefs/db186.pdf.

United Orthopedic Corporation Enters U.S. Market

March 5, 2014

United Orthopedic Corporation Enters U.S. Market

International leader brings FDA-approved hip and knee replacement products to American orthopedic surgeons.

IRVINE, Calif.—Today, United Orthopedic Corporation (UOC) – a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments – announced its entrance into the American market, offering clinically proven, safe and cost-effective hip and knee devices through its U.S. subsidiary, UOC USA.

“United Orthopedic Corporation is the first Asian orthopedic company to receive FDA approval for join reconstruction,” said Calvin Lin, president of UOC USA. “For the past 20 years we’ve been recognized for our innovative products and we are excited to bring our high-performing line of hip and knee replacement systems to American orthopedic surgeons.”

Established in 1993 and headquartered in Taiwan, UOC has been supplying and supporting orthopedic practitioners and institutions around the world with arthroplasty implant and instrument designs created by its vertically integrated, in-house manufacturing team. Its innovative designs are based on firsthand practitioner input, as well as rigorous clinical research, and are known for meeting world quality assurance standards. UOC products are currently selling in 22 countries worldwide and been used in more than 160,000 cases to date.

 “I’ve been using the U2 Knee™ System from UOC for seven years and believe the design and quality of UOC’s products can help to improve the lives of arthroplasty patients all around the world,”, said Thomas Ferro, M.D., an orthopedic surgeon and medical director at the Bone and Joint Center in Arroyo Grande, Calif. “In addition to quality joint replacement systems with great range of motion, UOC also offers surgeon-friendly instrument design which saves time on the operating table. Results from an outstanding seven-year clinical study will be presented at the ICJR Pan Pacific Congress this summer.”

“Because our manufacturing process is vertically integrated,” continued Lin, “we are able to oversee every aspect of our products’ manufacturing – from the initial design to packaging the finished product. This integration allows us to offer outstanding quality and provide incredibly responsive service.”

According to the Centers for Disease Control and Prevention (CDC), 332,000 hip and 719,000 knee replacements are performed in the United States each year in order to increase mobility, improve the function of the joint, and relieve pain.

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About United Orthopedic Corporation
United Orthopedic Corporation (UOC) is a leading international designer, manufacturer, and distributor of innovative, regulatory compliant orthopedic implants and instrument sets used by surgeons around the globe. Our offering includes a flexible range of clinically proven solutions used to perform total hip/knee replacements and revisions, plus clinical education, service and support for surgeons and hospital staff. UOC operates Quality Management Systems (QMS) that comply with ISO 9001/13485, FDA, and CE requirements. For more information about United Orthopedic Corporation, visit www.uocusa.com.

Media Contact:
Tiffany Lin
tiffany.lin@uocusa.com
Tel: +1 949-328-3366