FDA 510(k) Clears DePuy’s New INHANCE Shoulder System
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the DePuy Synthes INHANCE™ Shoulder System for use in shoulder replacement procedures.
According to the FDA 510(k) document, the INHANCE Shoulder System reverse total shoulder with a humeral stem is indicated for “primary, fracture or revision total reverse shoulder replacement procedures” to address “severely painful, disabling, arthritic joint”; “fractures of the humeral head (with Short Humeral Stems)”; “fractures of the proximal humerus (with Standard or Long Stems)”; and “revisions of previously failed shoulder joint replacements.”
The INHANCE Shoulder System is “for use in patients whose shoulder joint has a gross rotator cuff deficiency.” The patient must be “anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.” Additionally, the system is “also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.”
In order to qualify for shorter and earlier 510(k) clearance the device must be substantially equivalent to a predicate device. According to the FDA 510(k) document, the primary predicate device is Biomet, Inc.’s Comprehensive Reverse Shoulder. The other predicate devices include Ignite Orthopedics LLC’s Ignite Anatomic Shoulder System and Biomet, Inc.’s Comprehensive Primary Shoulder Stems.
Interesting New Features
DePuy’s new INHANCE™ system is coming to market with a number of interesting features including a 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; and ONE STEP PREP™ Glenoid Reamers.
Warsaw, Indiana-based Ignite Orthopedics submitted the 510(k) application to the FDA. DePuy Synthes, the orthopedics company of Johnson & Johnson, acquired INHANCE through an agreement with Ignite Orthopedics.
Andrew Jawa, M.D., an orthopedic surgeon at New England Baptist Hospital, helped develop the INHANCE Shoulder System and noted, “The INHANCE Shoulder System can be used for an anatomic or reverse shoulder procedure offering the surgeon and OR [operating room] staff a streamlined and effective shoulder system.”
Dr. Jawa continued, “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.”