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United Orthopedic Corporation Announces FDA Clearance for Vitamin E Highly Cross-Linked Polyethylene Hip Liner

November 27, 2018

  1. E-XPETM Designed to Provide Wear Resistance with Reduced Risk of Oxidation is Now Available in Both Knee Inserts and Hip Liners

IRVINE, Calif., November 27, 2018 – United Orthopedic Corporation, a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments, today announced that the U.S. Food and Drug Administration has cleared its vitamin E highly cross-linked polyethylene (E-XPETM) hip liner. The E-XPETM is the new generation of highly cross-linked polyethylene blended with vitamin E to enhance wear resistance without compromising oxidative stability and mechanical properties.

“Oxidation continues to be a concern for surgeons. Over time, wear of conventional polyethylene can generate debris in the joint, triggering local inflammation that results in bone loss which is one of the biggest causes of late-term failure in hip and knee replacements,” said Calvin Lin, President of United Orthopedic Corporation USA. “Clearance of our E-XPETM, a vitamin E highly cross-linked polyethylene, provides surgeons with an alternative implant for their patient. Our vertically integrated manufacturing process affords us the flexibility to design, manufacture and distribute implants or instruments that address many of the most significant needs in the orthopedic industry.”

Vitamin E is an effective biological antioxidant which helps prevent the oxidative degradation of cell membrane phospholipids. When added to ultra-high molecular weight polyethylene (“UHMWPE”), vitamin E performs a similar role by helping to prevent oxidation of the polyethylene chains.1 Vitamin E -stabilized UHMWPE is a biocompatible material with good mechanical, wear, and oxidative proprieties. Results from accelerated aging tests show that E-XPETM inserts and liners exhibited a 60 percent and 75 percent reduction, respectively, in gravimetric wear2. E-XPETM material provides greater strength in comparison to re-melted highly crosslinked polyethylene while maintaining oxidation resistance as demonstrated in mechanical tests.

An estimated 4.7 million Americans have undergone total knee arthroplasty (“TKA”) and 2.5 million have undergone total hip arthroplasty (“THA”).The prevalence of THA rises to nearly 6 percent by 80 years of age. The prevalence of TKA rises to nearly 10 percent by 80 years of age.3

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About United Orthopedic Corporation
United Orthopedic Corporation is a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instrument sets.

The company offers clinically proven solutions used in primary and revision total hip/knee replacement in addition to oncology applications. The company has implemented and maintains Quality Management Systems compliant with ISO 13485, FDA and CE requirements. To learn more visit www.uocusa.com.

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

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1 Gigante A, Bottegoni C, Ragone V, Banci L. Effectiveness of Vitamin-E-Doped Polyethylene in Joint Replacement: A Literature Review. J Funct Biomater 2015; 6(3):889-900.

2 Chang TW, Cheng YW, Lu CK, Liau JJ. Is Highly Cross Linked UHMWPE Blended with Vitamin E a Viable Reduction Wear in TKA? Presented at Orthopaedic Research Society, 2017, San Diego, CA.

3 Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE, Steiner CA et al. Prevalence of Total Hip and Knee Replacement in the United States. J Bone Joint Surg Am 2015; 97(17):1386-97.

United Orthopedic Corporation Announces UTS™ Hip Stem and an Extension of its U-Motion II™ Acetabular System Are Now Available

November 1, 2018

United Orthopedic Corporation Announces UTS™ Hip Stem and an Extension of its U-Motion II™ Acetabular System Are Now Available

IRVINE, Calif., November 1, 2018 – United Orthopedic Corporation, a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments, today announced that the UTS™ (United Tri-tapered Short Stem) hip stem and an extension of the U-Motion II™ Acetabular System are now available to surgeons in the U.S.

"The UTS hip stem and U-Motion II extension reflect our commitment to addressing some of the challenges in today’s hip replacement market – reducing dislocations and providing solutions that support rapid recovery from surgery,” said Calvin Lin, President of United Orthopedic Corporation USA. "Since the launch of these products at this year’s American Academy of Orthopaedic Surgeons Annual Meeting, we have received positive feedback from orthopedic surgeons, citing easier insertion of the hip stem, greater range of motion and improved stability."

The UTS hip stem is a tapered wedge short stem suitable for less invasive primary hip replacement. It is designed for easier insertion through small incisions and requires simpler femoral preparation, enabling rapid recovery. Shorter stems preserve bone, which allows for more favorable conditions in future revisions.1 The UTS hip stem is available in 14 refined proximal sizes. Its features include standard and high offset options for restoring joint biomechanics, and a reduced lateral shoulder designed to conserve bone in the greater trochanter.

"The shortened stem length and plasma coating coupled with the unique shape and properties of the UTS stem afford greater stability at the time of implantation." said Richard Steinfeld, M.D., a practicing orthopedic surgeon from Orthopaedic Center of Vero Beach, Fla. "This provides for greater bone conservation and affords patients the ability to fully weight bear immediately following their surgical procedure."

"The UTS hip stem offers some unique advantages over other hip stems on the market. The proximal porous ingrowth surface and tapered design allows for early weight bearing while preventing subsidence. Multiple offset options are available, allowing fine tuning of the soft tissue balance and stability during surgery." said Ronald Hillock, M.D., an orthopedic surgeon at the Nevada Orthopedic & Spine Center, in Las Vegas, Nev. "The instruments are well thought out and streamlined. I have been pleased with my initial UTS experience."

The extension of the U-Motion II Acetabular System for total hip replacement surgery includes a 50mm acetabular cup and cup liner, which is compatible with the 36mm BIOLOX® delta ceramic and CoCrMo metal femoral heads. The 36mm femoral head with the new U-Motion II 50mm Acetabular cup is designed to provide patients a greater range of motion2, increase jumping distance, improve stability and lower the risk of dislocation.

The demand for primary total hip arthroplasties is estimated to grow by 174% to 572,000 by 2030, while the demand for hip revisions is projected to double by 2026.3 Dislocation continues to be one of the most common causes of failure after primary and revision total hip arthroplasty. Clinical studies show large femoral heads decrease the incidence of dislocation after total hip arthroplasty.4

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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

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1 Molli RG,et al. A Short Tapered Stem Reduces Intraoperative Complications in Primary Total Hip Arthroplasty. Clin Orthop Relat Res. 2012 Feb;470(2):450-61.

2 Guyen O. Constrained liners, dual mobility or large diameter heads to avoid dislocation in THA. EFORT Open Reviews. 2016;1(5):197-204. doi:10.1302/2058-5241.1.000054.

3Kurtz, et al. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5.

4Howie, et al. Large femoral heads decrease the incidence of dislocation after total hip arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012 Jun 20;94(12):1095-102. doi: 10.2106/JBJS.K.00570.

United Orthopedic Corporation Launches UTSTM Hip Stem and an Extension of its U-Motion IITM Acetabular System at the American Academy of Orthopaedic Surgeons Annual Meeting

March 7, 2018

United Orthopedic Corporation Launches UTSTM Hip Stem and an Extension of its U-Motion IITM Acetabular System at the American Academy of Orthopaedic Surgeons Annual Meeting

IRVINE, Calif., March 7, 2018 – United Orthopedic Corporation, a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments, announced today, at the American Academy of Orthopaedic Surgeons Annual Meeting in New Orleans, the launch of the UTSTM (United Tri-tapered Short Stem) hip stem and an extension of the U-Motion IITM Acetabular System.

“We are committed to developing quality, innovative orthopedic products that improve patient outcomes and address the market’s needs,” said Calvin Lin, President of United Orthopedic Corporation USA. “Our unique vertically integrated manufacturing model has enabled us to launch two products which provide surgeons with more treatment options for total hip replacement. One is the UTSTM hip stem, which facilitates less invasive surgery and aids in rapid recovery. The other is a new cup and cup liner – an extension of the U-Motion IITM Acetabular System – which is designed to reduce the risk of dislocation following a total hip replacement.”

The UTSTM hip stem – ideal for the direct anterior approach for total hip replacement – is a tapered wedge short stem suitable for less invasive primary hip replacement surgery. It is designed for easier insertion through small incisions and requires simpler femoral preparation, enabling rapid recovery. Shorter stems preserve bone, which allows for more favorable conditions in future revisionsi. The UTSTM hip stem is available in 14 refined proximal sizes. Its features include:

  • Standard and high offset options for restoring joint biomechanics
  • Triple taper design with Titanium Plasma coating that provides initial fixation and enhances rotation stability
  • Reduced lateral shoulder designed to conserve bone in the greater trochanter

The demand for primary total hip arthroplasties is estimated to grow by 174% to 572,000 by 2030, while the demand for hip revisions is projected to double by 2026. Dislocation continues to be one of the most common causes of failure after primary and revision total hip arthroplasty. Clinical studies show large femoral heads decrease the incidence of dislocation after total hip arthroplasty.

The extension of the U-Motion IITM Acetabular System for total hip replacement surgery includes a 50mm acetabular cup and cup liner, which is compatible with the 36mm BIOLOX® delta ceramic and CoCrMo metal femoral heads. The pole thickness of the liner is 5.3mm, which is greater than ISO 21315’s requirement of 5mm to reduce the risk of breakage. The 36mm femoral head with the new U-Motion IITM 50mm Acetabular cup will provide patients a greater range of motion , increase jumping distance, improve stability and lower the risk of dislocation.

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

# # #

i Molli RG,et al. A Short Tapered Stem Reduces Intraoperative Complications in Primary Total Hip Arthroplasty. Clin Orthop Relat Res. 2012 Feb;470(2):450-61.

ii Kurtz, et al. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5.

iiiHowie, et al. Large femoral heads decrease the incidence of dislocation after total hip arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012 Jun 20;94(12):1095-102. doi: 10.2106/JBJS.K.00570.

ivGuyen O. Constrained liners, dual mobility or large diameter heads to avoid dislocation in THA. EFORT Open Reviews. 2016;1(5):197-204. doi:10.1302/2058-5241.1.000054.

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 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.