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Stryker (SYK) Gets FDA 501k Clearance for Pangea Trauma Systems

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Stryker (SYK - Free Report) announced that it has gained 510k clearance from the FDA for its Pangea systems, including Femur, Fibula, Tibia, Humerus and Utility.

The FDA clearance for Pangea systems will boost Stryker’s comprehensive portfolio of devices for a wide range of trauma needs.

The Pangea systems is an intuitive and streamlined instrumentation and implant tray that includes 20 anatomic plates and 13 utility plates accessible under one platform. The systems has been designed collaboratively by world-renowned orthopaedic surgeons who offered an evidence-based design for implant fit. It will offer solutions that will enhance plate fit and screw placement. The systems will also include anatomically contoured implants in patient populations with a wide variety of fracture patterns.

The launch of this new system should bring additional revenues for Stryker’s Trauma business unit going forward. More details will be available about the Pangea systems when Stryker presents it at the Annual Orthopaedic Trauma Association meeting, which is to be held in Seattle from Oct 18 to Oct 21.

Price Performance

Stryker’s shares have risen 30.5% year to date against the industry’s decline of 3.9%. The S&P 500 Index has gained 14.5% in the same time frame.

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Industry Prospects

Per a report by Maximize Market Research, the trauma implant market was valued at $56.76 billion in 2022. It is anticipated to reach $94.16 billion by 2029 at a CAGR of 7.5%.

Factors like rising incidence of orthopedic disorders and injuries, rapidly growing aging population, increasing adoption of robot-assisted surgical instruments implanted medical device, and widespread use of orthopedic implants to treat musculoskeletal and orthopedic disorders and injuries are expected to contribute to this improvement. A rising number of joint replacements and sports injuries will be the other key drivers of the market.

Given the market potential, the availability and adoption of the Pangea systems is likely to bolster Stryker’s business globally.

Recent Development

Last month, Stryker reported second-quarter 2023 earnings, wherein both earnings and revenues beat were above market expectations. The company witnessed strong performance across its segments in the United States. Strong International sales also buoy optimism. SYK expects the momentum to continue in the second half of 2023 on the back of ongoing procedural recovery and a strong order book for capital equipment. Moreover, the expansion in both gross and operating margins is reassuring.

In July, Stryker announced the commercial launch of its Q Guidance system with Cranial Guidance software in the United States. The new navigation system will provide image-based planning and intraoperative guidance. It will assist surgeons in positioning instruments and identifying patient anatomy during cranial surgery.

The same month, Stryker launched its fully autonomous guidance system, Ortho Q Guidance, designed specifically for its orthopedic customers. The Ortho Guidance software works with Ortho Q to offer a smart and streamlined workflow for Express Knee, Precision Knee and Versatile Hip procedures, thereby increasing speed and efficiency in the operating room.

Zacks Rank and Stocks to Consider

Stryker currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Align Technology (ALGN - Free Report) , HealthEquity, Inc. (HQY - Free Report) and McKesson Corporation (MCK - Free Report) .

Align Technology, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 17.5%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

ALGN’s earnings surpassed estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 1.76%. The company’s shares have risen 57.5% year to date compared with the industry’s 12% growth.

HealthEquity, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 22%. HQY’s earnings surpassed estimates in three of the trailing four quarters and missed once, delivering an average surprise of 9.1%.

The company’s shares have rallied 10.4% year to date against the industry’s 10.6% decline.

McKesson, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 10.7%. MCK’s earnings surpassed estimates in three of the trailing four quarters and missed once, delivering an average surprise of 8.1%.

The stock has rallied 12.2% year to date compared with the industry’s 12% growth.

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