FDA Clears Cost Saving Wrist Plating System

The Orthopaedic Implant Company of Reno, Nevada, says its newly FDA 510(k) cleared wrist plating technology "significantly" reduced costs for ambulatory surgical centers (ASCs) and hospitals treating distal radius fractures.

"How exactly?" we asked the company.

53% Reduced Costs

Company CEO Itai Nemovicher told us, “For more than ten years, we’ve consistently delivered on the promise of cost savings in combination with exceptional clinical outcomes with all of our technology—everything from our cannulated screws to our external fixation system to our locking plates. This includes clinical literature on our original distal radius plate, which reduced costs by 53% in comparison to conventional offerings. Despite the many upgrades we’ve made with the DRPx, the pricing is exactly the same as the original implant. It’s the right thing to do.”

DRPx Locking Distal Radius Plate System

The DRPx Locking Distal Radius Plate System, according to an August 4, 2021 company announcement, features "an enhanced" ergonomic design and, according to FDA documents, is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

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

The system, designed with Type II anodized titanium, also includes instruments used to implant the plates and features:

• Pre-contoured anatomic plates
• Low-profile plate and screw design to minimize soft tissue impingement
• Variable angle and fixed angle locking screws, locking pegs, and non-locking screws provide optionality for any technique
• Distal window for graft and/or fracture visualization
• Indicator lines for improved guidance and adjustment
• A full spectrum of targeting instrumentation that facilitates precise and fast drilling trajectories

Nikola Babovic, M.D., of the Reno Orthopedic Center, noted that wrist fractures are one of the most common injuries treated by orthopedic surgeons. "For those patients who benefit from surgical treatment, it is important to do so quickly, safely, and predictably. With the many barriers surgeons face in providing this type of care in today's health care system, there has been a shift towards the outpatient surgical setting. Lowering the cost of internal fixation devices eliminates cost as the rate limiting step for successfully moving orthopedic trauma into the surgery center setting."

"The creation of a truly high value distal radius plate such as the DRPx is long overdue, as it will help surgery centers reduce the cost of care without sacrificing quality. These savings can be passed directly to patients, especially those who are underinsured or paying out of pocket for medical care," concluded Babovic.

Nemovicher added that a new standard needs to be set clinically and financially in orthopedics, "and that's what we're doing. DRPx can compete with the most feature-rich distal radius plates on the market. It is engineered to support exceptional clinical outcomes and reduce costs while providing surgeons with much-needed familiarity and flexibility when it comes to technique."