Stryker receives FDA clearance for new total ankle replacement system

Published 25/06/2025, 13:26
Stryker receives FDA clearance for new total ankle replacement system

PORTAGE, Mich. - Medical technology company Stryker (NYSE:SYK), a prominent player in the Healthcare Equipment & Supplies industry with a market capitalization of $147.69 billion, announced it has received FDA 510(k) clearance for its Incompass Total Ankle System, designed for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. According to InvestingPro data, the company maintains a GREAT financial health score, supporting its continued innovation in medical technology.

The new system combines technologies from Stryker’s existing Inbone and null ankle replacement platforms into a single solution. According to the company’s press release statement, the Incompass system incorporates Adaptis Boney Ingrowth Technology and redesigned instrumentation aimed at supporting long-term fixation, surgical flexibility, and streamlined workflow. This innovation comes as Stryker continues to demonstrate strong business performance, with revenue growing at 10.76% over the last twelve months to $23.22 billion.

The development of the system was informed by data from more than 85,000 CT scans and 100,000 clinical cases, according to the company. Stryker built the system using its Orthopaedic Modeling & Analytics platform combined with arthritic ankle scans from its Prophecy Surgical Planning System.

Key enhancements to the system include a redesigned alignment system for greater control across multiple planes, updated implant holders and trial tools, and instrumentation refinements intended to reduce surgical steps and setup time.

"By building on decades of clinical experience and leveraging extensive data insights, we’re setting a new standard," said Adam Jacobs, vice president and general manager of Stryker’s Foot & Ankle business, in the announcement.

The system is designed to provide surgeons with multiple implant and instrumentation options to support patient-specific care for those requiring total ankle replacement procedures.

In other recent news, Stryker Corporation has been upgraded by Moody’s Ratings, moving its senior unsecured notes to A3 from Baa1, with a stable outlook. This upgrade reflects expectations of continued strong growth, supported by new product launches and acquisitions. Barclays has maintained its Overweight rating on Stryker, with a price target of $443, citing the success of its MedSurg and NeuroTech division, which has a 10.4% compound average growth rate over the past 12 years.

Additionally, Stryker has received FDA 510(k) clearance for its OptaBlate basivertebral nerve ablation system, aimed at alleviating chronic back pain. Shareholders have approved amendments to key incentive plans, including the 2011 Long-Term Incentive Plan and the 2008 Employee Stock Purchase Plan, reflecting support for the company’s strategic direction. Furthermore, Stryker announced an increase in its quarterly dividend to $0.84 per share, marking a 5.0% rise from the previous year.

These developments underscore Stryker’s ongoing commitment to growth and innovation in the medical technology sector.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers
© 2007-2025 - Fusion Media Limited. All Rights Reserved.