Search

J&J’s Knee Surgery Robot Cleared for Expanded Use

In 2013, Stryker acquired Mako Surgical and has since maintained a leading position in the robotics field. In 2019, Zimmer Biomet's Rosa knee system received 510(k) clearance, entering the market. J&J took longer to enter the market, with its Velys product first receiving FDA clearance in 2021. Recently, the company has expanded the system's scope of use.

In 2013, Stryker acquired Mako Surgical and has since maintained a leading position in the robotics field. In 2019, Zimmer Biomet’s Rosa knee system received 510(k) clearance, entering the market. J&J took longer to enter the market, with its Velys product first receiving FDA clearance in 2021. Recently, the company has expanded the system’s scope of use.

Strong Growth in the UKA Market

The new FDA clearance covers the application of Velys in unicompartmental knee arthroplasty (UKA). J&J stated that this surgery can support bone preservation and shorten recovery time, but due to challenges such as smaller incisions and lower visibility, the procedure has not been fully utilized.

In a J&J press release, orthopedic surgeon John Redmond stated, “Achieving precise alignment and optimal implant positioning is crucial for long-term success, and the ability to achieve this in a reproducible manner remains an unmet need in the UKA field.” Redmond noted that Velys “will enable more personalized surgeries and help achieve reproducible results” with higher precision and accuracy.

Surgeons added that ambulatory surgery centers (ASCs) are settings where Velys can play a role.

While other robots are already available for partial knee surgeries, J&J believes its device design may be better suited for ASCs. J&J CEO Joaquin Duato discussed the comparison between Velys and other robots like Stryker’s Mako at the 40th Annual Bernstein Strategic Decisions Conference in May.

“We’ve heard from orthopedic surgeons that Velys is more compact and takes up less space than competitor robots,” Duato said. “Therefore, especially in crowded operating rooms and even in the context of ASCs, having a smaller footprint like Velys is an advantage. We have the opportunity to regain market share and grow our knee platform.”

J&J has not yet disclosed commercialization details for Velys in the new indication. The company believes the “strong performance in the hip and knee areas” was a driving factor for the 4.3% year-over-year growth in its orthopedics division in the first quarter of this year.

Related Chinese Manufacturers

In recent years, various Chinese companies have been developing knee replacement systems, with several products approved by the NMPA:

  • Hangzhou Jianjia Medical Technology Co., Ltd.
  • Hangzhou Scalpels Robot Co., Ltd.
  • Suzhou MicroPort Navigation Technology Co., Ltd.
  • Beijing Natong Medical Robot Technology Co., Ltd.
  • Dabo Medical Technology Co., Ltd.
  • Beijing Natong Medical Robot Technology Co., Ltd.
  • Kuangrui Intelligent Technology (Suzhou) Co., Ltd.
  • Beijing Chunlizhengda Medical Instruments Co., Ltd.

About Accel

Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.

Share the Post:

Related Posts

September 510K Clearance Highlights

Accel Groups select ten medical devices or in vitro diagnostic reagents from the monthly 510(k) clearance list (five from Chinese manufacturers and five from foreign manufacturers) for brief introductions.

Read More