Consumers Union is pushing device makers to equip patients with warranties so they will have a better understanding of how long an implant is expected to last and a clear process to follow in the event that it fails prematurely. Ultimately, warranties will encourage companies to make their devices safer and more durable, according to Consumers Union.
Moirai Orthopaedics, L.L.C., a Metairie, Louisiana based orthopaedic implant development company, is pleased to announce it has received CE mark approval for its new Pyrocarbon Implant Replacement (PIR) System. The PIR System, developed in conjunction with the not-for-profit Fellowship of Orthopaedic Researchers, is intended to treat patients with focal chondral and osteochondral defects of the medial femoral condyle of the knee.
In a draft guidance document, FDA has placed its summary of ideas regarding biocompatibility and possible changes that could eventually replace FDA G-95 Blue Book Memorandum #G95-1 on biocompatibility. The draft document has been out since April and is widely available, though it has not been formally released.
The lightweight skeletons of organisms such as sea sponges display a strength that far exceeds that of manmade products constructed from similar materials. Scientists have long suspected that the difference has to do with the hierarchical architecture of the biological materials...
California spinal devices maker NuVasive Inc. has recently gotten very popular with law firms, which began piling onto a class action lawsuit following the revelation that the company is under investigation by the Health & Human Services Dept.'s Office of the Inspector General.
A new ASTM International standard will provide a consistent method for analyzing hip stems used in hip replacement surgery. The new standard, ASTM F2996, Practice for Finite Element Analysis (FEA) of Nonmodular Metallic Orthopaedic Hip Femoral Stems, was developed by Subcommittee F04.22 on Arthroplasty, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.
While the use of disposables in healthcare is certainly nothing new, their implementation as instrumentation in orthopedic procedures is. “Disposables in the O.R.” takes a look at the benefits of this trend.
The European market for orthopedic biomaterials saw a decline between 2010 and 2012 due to a period of economic uncertainty and severe budgetary restrictions. However, this rate of decline has been diminishing, a promising sign for future growth.
Wenzel Spine, Inc., a medical device company focused on providing minimally invasive, stand-alone alternatives to traditional spinal fusion, announced today that it has been granted a new patent related to Wenzel Spine’s Zero-Profile VariLift® Stand-Alone Expandable Interbody Fusion System.
SpineGuard has announced that it has received product certification ("Ninsho") to market its Classic and Curved PediGuard® products in Japan. “This regulatory clearance is the result of a diligent collaborative process with our Japanese partners, notably Surgical Spine Inc...
Unlike humans, planarian flatworms have the remarkable ability to regrow any missing body part, making them an ideal model with which to study the molecular basis of regeneration. Over the years scientists have learned that planarians mount recovery responses that differ depending on the severity of the injury they suffer.
Biomet amended its Q4 and annual earnings report to reflect a swing to red in Q4 and much deeper losses for the full year compared to earlier reports. The Warsaw, Ind.-based orthopedics company posted losses of $221.2 million on $784 million in sales during the 3-month period ended May 31, 2013.
The U.S. Food and Drug Administration (FDA) hit Allendale, NJ-based Stryker’s Spine division with a Class I recall for the company’s OASYS Midline Occiput Plate. According to reports, Stryker learned that a post-operative fracture can occur in the pin that connects ...
While machining may not be specified as much as it once was in the medical device industry (outside of the orthopedic realm, that is), it is still very much a necessary component fabrication process for this industry. In fact, machining is being utilized across an array of device sectors, from surgical tools, fixation devices, and dental implants to components for medical pumps, instrumentation, and implantables.
While the use of disposables in healthcare is certainly nothing new, their implementation as instrumentation in orthopedic procedures is. Offering an array of benefits for OEMs and hospitals alike, such as cost savings, improved efficiencies, and enhanced safety, without sacrificing the durability and strength of more traditional instruments, it’s no wonder this trend is occurring.
Researchers at Missouri University of Science and Technology have developed a type of glass implant that could one day be used to repair injured bones in the arms, legs and other areas of the body that are most subject to the stresses of weight. This marks the first time researchers have shown a glass implant strong enough to bear weight can also integrate with bone and promote bone growth.
A surgeon at The Ohio State University Wexner Medical Center is the first in the United States to consult with a distant colleague using live, point-of-view video from the operating room via Google Glass, a head-mounted computer and camera device.
During this procedure at the medical center’s University East facility, Dr. Christopher Kaeding wore the device as he performed ACL surgery on Paula Kobalka, 47, from Westerville, Ohio, who hurt her knee playing softball. As he performed her operation at a facility on the east side of Columbus, Google Glass showed his vantage point via the internet to audiences miles away.
Precision Micro, Europe’s largest specialist contract chemical etching operation, has developed a new process route that it claims can reduce the cost of many precision sharp parts including sagittal/oscillating orthopaedic saw blades. Traditionally, such sharp-toothed blades have been manufactured using laser technology...
Biomet will go to bat over its M2A-magnum metal-on-metal hip implants after failing to convince an Indiana federal judge that a personal injury lawsuit was preempted by FDA rules. The plaintiff, Leslie Caccia, sued Biomet for a supposedly defective metal-on-metal hip implant in what is now part of a larger multi-district litigation.
SpineGuard Receives FDA 510(k) Clearance for Miniaturized and Directional Versions of Its Pediguard® PlatformAugust 28, 2013 11:40 am | by Business Wire | News | Comments
SpineGuard announced today that it has received FDA 510(k) clearance of three new products that complete its PediGuard platform of single-use drilling instruments which secure the pedicle screw pilot hole: Two miniaturized versions of its classic and curved range, and a directional version of its cannulated series.
The FDA cleared a next-generation sternum compression band made by California bone repair company Dallen Medical. The company's Compressyn Band, used for breastbone closure, features a new polymer coating that older lines of the Compressyn products lack.
LDR, a privately held medical device company offering exclusive spinal implant technologies for both non-fusion and fusion applications, today announced that it has received a letter of approval from the U.S. Food and Drug Administration (FDA) allowing the commercial sale and distribution of the Mobi-C Cervical Disc (Mobi-C) for two-level indications...
The BMI works by interpreting brain waves that allow patients to control, with their thoughts, robotic legs and below-elbow amputees to control neuroprosthetic limbs. Contreras-Vidal has partnered with Dr. Robert Grossman at TMHRI on the research project.
Two Biomet subsidiaries are on the hook for some $2.7 million in royalty payments to a prominent spine surgeon it stopped paying in 2008, after a New Jersey appeals court upheld a lower court's ruling in Dr. Neil Kahanovitz's favor. Kahanovitz, the former president of the North American Spine Society, sued Biomet units Electro-Biology Inc. and EBI LLC...