Home DePuy Synthes Receives FDA 510(k) Clearance for INHANCE™ Shoulder System for Reverse Total Shoulder Arthroplasty

DePuy Synthes Receives FDA 510(k) Clearance for INHANCE™ Shoulder System for Reverse Total Shoulder Arthroplasty

May 20, 2022 19:00 CST Updated May 23, 13:20
Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

Synthes GmbH

Producer of Trauma and Maxillofacial Surgical Tools

Recently, Johnson & Johnson announced that the INHANCE™ Shoulder System from its orthopedic subsidiary DePuy Synthes has received 510(k) clearance from the FDA for Reverse Total Shoulder Arthroplasty (RTSA). The INHANCE Shoulder System is the first-to-market, fully convertible shoulder arthroplasty system designed to help streamline existing workflows for surgeons and operating room staff.

Image Source: DePuy Synthes Official Website

In 2020 alone, reverse shoulder arthroplasty accounted for 70% of all shoulder arthroplasties performed in the United States. Surgeons typically perform reverse total shoulder arthroplasty in cases of shoulder arthritis and severe rotator cuff tendon deficiency. In complex scenarios, due to various factors including the severity of humeral bone quality and glenoid bone loss, or the extent of rotator cuff deficiency, surgeons may need to modify their approach mid-procedure. According to Andrew Jawa, MD, an orthopedic surgeon at New England Baptist Hospital: "The INHANCE Shoulder System can be used for both anatomic and reverse shoulder surgeries, offering a streamlined and efficient solution for surgeons and operating room staff, with a comprehensive system that includes the necessary tools from preoperative planning to intraoperative use."

Previously, the Inhance system received approval for anatomical shoulder joint replacement — the implant mimics the natural ball-and-socket structure of the shoulder, where the rounded top of the upper arm bone fits into the socket of the shoulder blade. Now, Johnson & Johnson Orthopaedics can offer reverse shoulder joint replacement devices, where the new joint works in the opposite direction: a metal ball replaces the socket of the shoulder blade, and the top of the humerus is fitted with a matching artificial socket.

Features of the INHANCE™ Shoulder System include:
• 135° neck shaft angle, with lateral option
• Comprehensive evaluation of the patient's condition for size selection
• 3D Laser-Printed R/SPEED™ Baseplate and Modular Baseplate with Central Screw and Central Column
• Advanced cross-linked vitamin E polyethylene, with the required wear resistance and oxidation stability
• ONESTEP PREP™ Glenoid Reamer

The INHANCE™ Shoulder System is also designed to shift the care setting for certain orthopedic surgeries to outpatient and ambulatory surgery centers, where economic value and operational efficiency are key considerations. The implants of the INHANCE™ Shoulder System are designed to preserve bone, provide immediate biologic fixation, and promote intraoperative flexibility while streamlining preparation for a variety of surgical treatment options.

"Adding reverse shoulder arthroplasty to our INHANCE Shoulder System is helping us transform patient care," said Rajit Kamal, Global President of DePuy Synthes. "This reinforces our commitment to innovation to address the most pressing needs of today’s surgeons and the market dynamics driving future clinical trends."

DePuy Synthes, Johnson & Johnson’s orthopaedics company, offers one of the most comprehensive orthopaedic portfolios in the world to treat millions of patients served. DePuy Synthes’ solutions include joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery, and sports medicine, as well as the VELYS™ Digital Surgery portfolio, designed to advance patient care while delivering clinical and economic value to healthcare systems worldwide.

In 1998, Johnson & Johnson acquired DePuy, becoming the leader in the orthopedics field; in 2011, Johnson & Johnson acquired Synthes GmbH, a Swiss medical device company, for approximately $21 billion, integrating it into its subsidiary DePuy to form DePuy Synthes. Through acquisitions, Johnson & Johnson has gradually built its core orthopedic business and expanded its orthopedic coverage, driving development through innovation. As one of the most important high-value consumable sectors, orthopedics remains highly popular. In the global orthopedic market in 2021, the businesses of the five giants—Johnson & Johnson's DePuy Synthes, Stryker, Zimmer Biomet, Medtronic, and Smith & Nephew—all achieved growth. Among them, Johnson & Johnson's orthopedic revenue reached $8.588 billion, increasing by 10.6% year-on-year, firmly maintaining its dominant position in the orthopedic field.