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Zimmer Biomet (ZBH) Receives FDA Nod for ROSA Hip System

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Zimmer Biomet Holdings, Inc. (ZBH - Free Report) recently announced the FDA 510(k) clearance of the ROSA Hip System for robotically-assisted direct anterior total hip replacement. This is the latest addition to the company's comprehensive ROSA Robotics portfolio, consisting of the ROSA Knee System, ROSA Partial Knee System and ROSA ONE.

The ROSA Hip also complements Zimmer Biomet’s ZBEdge Connected Intelligence Suite. Its integration with the ZBEdge advances the company’s vision to translate pre-, intra-and post-operative data into actionable clinical insights to aid in informed personalized care decision-making.

More on the Features of ROSA Hip

The ROSA Hip is intended to assist direct anterior surgeons with preparation, positioning and component impaction, while intra-operatively quantifying cup orientation, leg length and offset. The intra-operative data collected by ROSA Hip is combined with pre- and post-operative data collected by mymobility with Apple Watch, a proprietary remote care management platform. This data is consolidated and analyzed by OrthoIntel Orthopedic Intelligence Platform to gain new clinical insights.

The ROSA Hip is compatible with multiple implant systems, including the Avenir Complete Hip System.

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The ROSA Hip is designed to easily adapt to a surgeon’s existing workflow. It enables surgeons to retain complete control over case planning and execution, while providing real-time data and visualization tools. It also provides support during component positioning, cup impaction and other critical steps of an anterior approach total hip replacement.

Per management, ROSA Hip has the potential to offer greater surgeons and patients’ confidence in contemporary total hip replacement by reducing the intra-operative variability and inconsistency.

Additional Features of the ROSA Hip

The ROSA Hip is a fluoroscopy-based tool. It additionally allows surgeons to create a personalized pre-operative surgical plan through the ONE Planner Hip within five minutes. It can also help to improve procedural efficiency with a simplified set-up (that doesn't require pins or reference arrays) and the convenience to use X-ray imaging instead of computed tomography (CT) scans.

Industry Prospects

Per a report published in Technavio, the global orthopedic surgical robots market is expected to see a CAGR of almost 44% by 2024. Factors driving market growth include increased adoption of robotic surgical platforms due to limitations associated with conventional surgeries, several advantages over-conventional surgeries, growing preference for minimally-invasive surgeries from hospitals and increase in strategic collaborations to develop advanced robotic platforms.

Given the substantial market prospects, the recent regulatory authorization of the ROSA Hip seems well-timed.

Notable Developments

In April 2021, Zimmer Biomet received FDA 510(k) clearance for the ROSA Partial Knee System for robotically-assisted partial knee replacement surgeries. The ROSA Partial Knee System added to the company’s ROSA Robotics portfolio. It is also a component of Zimmer Biomet's ZBEdge. The ROSA Partial Knee System is compatible with Persona Partial Knee, a leading partial knee implant system with a clinically-proven legacy and a high rate of patient satisfaction.

In March 2021, the company launched ZBEdge Connected Intelligence Suite of digital and robotic technologies which are purposefully engineered to deliver transformative data-powered clinical insights, shared seamlessly across the patient journey, to improve patient outcomes. The notable ZBEdge technologies include the ROSA Robotics Platform, Signature ONE Surgical Planning, the Zimmer Biomet iAssist Knee Alignment System, among others.

Share Price Performance

The stock has underperformed its industry over the past year. It has grown 5.1% compared with the industry’s 12.1% growth.

Zacks Rank and Key Picks

Currently, Zimmer Biomet carries a Zacks Rank #4 (Sell).

A few better-ranked stocks from the Medical-Products industry include VAREX IMAGING (VREX - Free Report) , Envista Holdings Corporation (NVST - Free Report) and BellRing Brands, Inc. (BRBR - Free Report) .

VAREX, sporting a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 5%. You can see the complete list of today’s Zacks #1 Rank stocks here.

Envista Holdings, sporting a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 26.8%.

BellRing Brands, carrying a Zacks Rank #2, has a long-term earnings growth rate of 25.3%.