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

INHANCE Total Shoulder System for Use in Reverse Total Shoulder Arthroplasty

The INHANCE Shoulder System is a first-to-market, fully convertible shoulder arthroplasty system that provides an efficient and intuitive plan to help simplify the surgeon and operating room (OR) staff’s existing workflow. 

Designed for hospitals as well as outpatient and ASC settings where economic value and operational efficiency are critical considerations.

 

Warsaw, IN – May 16, 2022 – Today, Johnson & Johnson MedTech* announced that the INHANCE™ Shoulder System from DePuy Synthes, the Orthopaedics Company of Johnson & Johnson,** has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in reverse total shoulder arthroplasty procedures. This clearance is in addition to the system’s already cleared use in anatomic shoulder arthroplasty and provides surgeons with interoperative flexibility.

In 2020 alone, reverse shoulder arthroplasty accounted for 70% of all total shoulder arthroplasty procedures in the U.S.1 Surgeons typically perform a reverse total shoulder arthroplasty when there is arthritis of the shoulder joint, and the rotator cuff tendons are severely deficient. In complicated cases, surgeons may need to change their approach mid-surgery due to multiple factors, including humeral bone quality and severity of glenoid bone loss, or the extent of rotator cuff deficiency.

“The INHANCE Shoulder System can be used for an anatomic or reverse shoulder procedure offering the surgeon and OR staff a streamlined and effective shoulder system,” said Andrew Jawa, MD, Orthopaedic Surgeon, New England Baptist Hospital. “This system contains the necessary tools from pre-op planning to intra-op flexibility with two trays of instruments to help ensure a consistent outcome.”

Features of the reverse system include:

  • 135° neck shaft angle with lateralized options
  • Sizing options to address a full range of patients
  • 3D laser printed R/SPEED™ Baseplates and Modular Baseplates with Central Screw and Central Post options
  • Advanced cross-linked Vitamin E polyethylene for desired wear characteristics and oxidative stability
  • ONE STEP PREP™ Glenoid Reamers

The INHANCE Shoulder System is also designed for the shift in site of care of certain orthopaedic procedures toward outpatient and ambulatory surgery centers where economic value and operational efficiency are critical considerations. The INHANCE Shoulder System's implants are designed to preserve bone, provide immediate and biological fixation, and facilitate intra-operative flexibility while simplifying preparation for various surgical treatment options.

“Adding the reverse total shoulder arthroplasty to our INHANCE Shoulder System is helping us transform patient care” said Rajit Kamal, Worldwide President, Sports Medicine & Shoulder Reconstruction, DePuy Synthes****. “This reinforces our commitment to innovation that addresses the most pressing needs of surgeons today and the market dynamics driving clinical trends of tomorrow.”

The INHANCE Shoulder System was designed in collaboration with a team of leading shoulder arthroplasty surgeons and is competitively positioned to address the increasing complexity of shoulder replacement procedures by integrating less invasive clinical options aligned with how surgeons approach patient care.

For more information visit www.depuysynthes.com.

About Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and re-imagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

About DePuy Synthes

DePuy Synthes, the Orthopaedics Company of Johnson & Johnson, provides one of the most comprehensive orthopaedics portfolios in the world that helps heal and restore movement for the millions of patients we serve. DePuy Synthes’ solutions, in specialties including joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery, and sports medicine, in addition to the VELYS™ Digital Surgery portfolio, are designed to advance patient care while delivering clinical and economic value to healthcare systems worldwide. Building on our proud product innovation and legacy of industry firsts, we are re-imagining the orthopaedic landscape with new advancements in medical technologies and digital surgery across the entire continuum of care to Keep People Moving today and tomorrow. For more information, visit www.depuysynthes.com.

 

*     Comprising the surgery, orthopaedics, vision, and interventional solutions businesses within Johnson & Johnson’s MedTech segment.

**     DePuy Synthes represents the products and services of DePuy Synthes Sales, Inc. and its affiliates.

***   Dr. Jawa is a design surgeon who helped develop the INHANCE Shoulder System and is a design surgeon and paid consultant of an affiliate of DePuy Synthes.

****  Rajit Kamal is an employee of Medical Device Business Services, Inc.

 

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the INHANCE Shoulder System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, Inc, any of the other Johnson & Johnson MedTech Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products, and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties, and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2022, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes, Inc. / the Johnson & Johnson MedTech Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

 

211979-220505 DSUS

© DePuy Synthes 2022. All rights reserved.

Please refer to the instructions for use for a complete list of indications, contraindications, warnings, and precautions.


1. DePuy Synthes. Analysis of Primary Shoulder Arthroplasty Anatomic and Reverse Volumes from 2016‐2020 Using Medicare SAF, IBM MDCD and IBM CCAE. Raynham (MA). February 2022.