- Zimmer Biomet Monday announced it received FDA 510(k) clearance for its Persona Revision knee system for knee replacement procedures.
- The implant components are designed to match a patient's anatomy, while the system allows surgeons to use their preferred surgical approach, the Warsaw, Indiana-based device maker said.
- The company said it expects to launch the system in the United States over the coming weeks.
Zimmer Biomet is counting on new products to sustain the momentum of a turnaround effort that saw business accelerate to its best growth in three years in the second quarter. Earlier in the year, the company had warned of flat sales.
"Management has delivered better than expected progress and operational trends in 2019 and the queued up product launches will drive an improving organic revenue growth trajectory," a Cowen equity research note on the company said Friday.
On the company's second-quarter conference call, CEO Bryan Hanson said quality remediation efforts are on track at its Warsaw North campus, and its engineering teams are now turning their focus back to innovation and its pipeline. Key products include the Rosa robotics platform, which gained FDA 510(k) clearance in January, and the flagship Persona knee.
Zimmer Biomet is working to catch up with rival Stryker, which has enjoyed a strong boost from the introduction of its Mako robotic system, especially in knee replacement procedures.
The Persona Revision system uses Zimmer Biomet's trabecular metal technology, a porous biomaterial made from elemental tantalum with properties similar to bone, the company said. The system also incorporates a bearing surface with Vitamin E designed to protect against oxidation and maintain wear resistance and strength.
Last month, the orthopaedic device maker was hit with a lawsuit from Conformis alleging Zimmer Biomet's Persona as well as other knee, hip and shoulder products infringe its patents. Conformis is looking to stand out in the crowded joint replacement market with customized knee implants tailored to a patient's anatomy.
The hip and knee replacement market is dominated by medtech giants including Stryker, Johnson & Johnson's DePuy Synthes, Zimmer Biomet and Smith & Nephew.