FDA clears cost-saving wrist electroplating system | Orthopedics Week

2021-11-25 03:19:48 By : Mr. Jin Yong

The Reno, Nevada-based orthopedic implant company said its newly FDA 510(k)-approved wrist electroplating technology "significantly" reduces the cost of outpatient surgery centers (ASC) and hospitals that treat distal radius fractures.

"How exactly?" We asked the company.

The company’s CEO Itai Nemovicher told us, “For more than ten years, we have consistently fulfilled our cost-saving commitments and used all our technologies to achieve excellent clinical results-from our hollow screws to our external fixators. The system goes to our locking plate. This includes clinical literature on our original distal radius bone plate, which has a cost reduction of 53% compared to traditional products. Although we have made many upgrades to DRPx, the price is The original implant is exactly the same. This is the correct approach."

DRPx Locking Distal Radius Plate System

According to the company's announcement on August 4, 2021, the DRPx Locking Distal Radius Plate System has an "enhanced" ergonomic design and is suitable for fixing intra- and extra-articular fractures and distal osteotomy radius according to FDA documents.

The system consists of titanium plates, bone nails, bone screws, and instruments for the distal radius to facilitate implantation. The bone plates come in a variety of sizes and are pre-shaped to match the anatomy of the distal radius. They accept 2.0 mm locking screws, 2.3 mm locking screws, and 2.6 mm and 3.5 mm locking and non-locking bone screws. The length of the bone screw ranges from 6 mm to 30 mm.

The system is designed with Type II anodized titanium, and also includes instruments for implanting steel plates, and has the following characteristics:

Nikola Babovic, MD, of the Reno Orthopedic Center, points out that wrist fractures are one of the most common injuries treated by orthopedic surgeons. "For those patients who benefit from surgical treatment, it is very important to perform surgery quickly, safely and predictably. As surgeons face many obstacles in providing this type of care in today's healthcare system, they have turned to outpatient surgery. Settings. Reducing the cost of internal fixation devices can eliminate costs as a speed-limiting step for successfully transferring orthopedic trauma to the surgical center."

"The creation of truly high-value distal radius plates (such as DRPx) should have been introduced long ago because it will help surgical centers reduce care costs without sacrificing quality. These savings can be passed on directly to patients, especially those with insufficient insurance. Or the patients who pay for the medical care out of their pockets," Babovic concluded.

Nemovicher added that new standards need to be set in the clinical and financial aspects of orthopedics, "This is what we are doing. DRPx can compete with the most feature-rich distal radius plate on the market. It is designed to support excellent clinical results and lower Cost, while providing surgeons with much-needed familiarity and flexibility in technology."

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