ZBH · 8-K · 20260805PR333761
Product Launch and Transition
ZIMMER BIOMET HOLDINGS, INC. · 2026-08-05 · Importance 31 · Surprise 42 · In source text
Zimmer Biomet received U.S. FDA 510(k) clearance for the next-generation ROSA Shoulder System and completed its first clinical cases. The system supports both glenoid and humeral bone preparation for anatomic and reverse shoulder techniques. The launch expands the company’s ROSA robotic technology portfolio into shoulder procedures and follows recognition for ROSA Knee with OptimiZe as a 2026 MedTech Breakthrough Award winner.
Key facts
- Company received U.S. FDA 510(k) clearance and completed first cases of the next generation ROSA Shoulder System source
- Three months Knees total net sales: $828.9 million (United States $455.0 million; International $374.0 million) source
- Six months Knees total net sales: $1,657.5 million (United States $924.1 million; International $733.4 million) source
- Three months Hips total net sales: $562.7 million (United States $288.5 million; International $274.1 million) source
- Six months Hips total net sales: $1,086.8 million (United States $566.1 million; International $520.7 million) source
- Company recognized ROSA Knee with OptimiZe as 'Best Healthcare Robotics Solution' in 2026 MedTech Breakthrough Awards source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | Company received U.S. FDA 510(k) clearance and completed first cases of the next generation ROSA Shoulder System |