Tenon Medical(R) Announces FDA 510(k) Clearance for Catamaran(R) SI Joint Fusion System
Rhea-AI Summary
Tenon Medical (NASDAQ:TNON) received FDA 510(k) clearance for its updated Catamaran SI Joint Fusion System. The clearance covers instrument upgrades and reclassification of select tools from disposable to reusable, intended to lower per-procedure costs and support gross margin and cash flow.
The Catamaran system uses a single titanium implant via a minimally invasive, inferior-posterior SI joint approach. Since its October 2022 U.S. launch, over 1,500 Catamaran Fixation Devices have been implanted.
Positive
- FDA 510(k) clearance for updated Catamaran SI Joint Fusion System
- Reclassification of instruments from disposable to reusable reduces per-procedure costs
- Reusable instrumentation expected to support gross margins and cash flow
- Over 1,500 Catamaran Fixation Devices implanted in the U.S. since October 2022
Negative
- None.
Market reaction after Catamaran SI 510(k) clearance: TNON -10.34% in the Jul 2 session
In the Jul 2 session, TNON declined 10.34%, reflecting a significant negative market reaction. Argus tracked a peak move of +33.6% during that session. Argus tracked a trough of -25.3% from its starting point during tracking. Our momentum scanner triggered 31 alerts that day, indicating elevated trading interest and price volatility. Trading volume was very high at 3.8x the daily average, suggesting heavy selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 01 | Public offering close | Negative | -0.1% | Closing of $4.2M public equity offering with attached warrants |
| Jul 01 | Public offering close | Negative | -0.1% | Company announcement of $4.2M offering closing and warrant terms |
| Jun 30 | Public offering pricing | Negative | -26.9% | Pricing of $4.2M equity offering with common and pre-funded warrants |
| Jun 30 | Public offering pricing | Negative | -26.9% | Company pricing of $4.2M public offering at $0.38 per unit |
| May 12 | 1Q26 earnings report | Positive | -11.6% | Strong revenue growth and margin expansion but ongoing net loss |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent financings and earnings releases were followed by consistently negative next-day moves, suggesting a tendency for the stock to sell off on capital-raising and financial updates.
Key Terms
510(k) clearance regulatory
sacroiliac joint medical
degenerative sacroiliitis medical
cortical bone medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
~ Updated clearance incorporates various instrument upgrades, as well as per-procedure costs, improving unit economics driven by the reclassification of certain instruments from disposable to reusable status ~
~ Clearance reflects Tenon's commitment to continuous innovation and operational efficiency, with reusable instrumentation expected to drive lower capex and logistical spend, contributing positively to gross margins and cash flow ~
LOS GATOS, CA / ACCESS Newswire / July 2, 2026 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering with certain sacro-pelvic disorders, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Catamaran® SI Joint Fusion System.
The updated clearance incorporates various instrument upgrades, as well as the reclassification of certain instruments from disposable to reusable status. These enhancements are designed to further improve the performance of the Catamaran System while delivering meaningful economic benefits to the Company by eliminating ongoing per-procedure costs previously associated with disposable instrumentation.
"This 510(k) clearance reflects our ongoing commitment to never-ending refinement of our Catamaran System - not only for the physicians who rely on it and the patients who depend on it, but also for the long-term financial health of our business," said Steven M. Foster, President and CEO of Tenon. "The instrument upgrades advance the procedural performance that our surgeon users have come to expect from the Catamaran platform, and the transition of select instruments from disposable to reusable status is a smart operational improvement that will reduce our per-procedure cost structure and contribute positively to our gross margins going forward. As we continue to drive commercial adoption across our growing portfolio, initiatives like this demonstrate that we are focused on building a sustainable, scalable business."
The Catamaran SI Joint Fusion System offers a novel, minimally invasive approach to the sacroiliac joint, utilizing a single, robust titanium implant that stabilizes and transfixes the SI joint along its longitudinal axis. The implant's inferior-posterior surgical approach is designed to navigate away from critical neural and vascular structures and into the strongest cortical bone. Since its national launch in October 2022, there have been over 1,500 Catamaran Fixation Devices implanted in patients throughout the United States suffering from sacroiliac joint disruptions and degenerative sacroiliitis.
About Tenon Medical, Inc.
Tenon Medical, Inc. is a medical device company dedicated to transforming care for patients with certain sacro-pelvic disorders. Tenon was incorporated in the State of Delaware in 2012 and currently offers two systems to treat a diseased sacroiliac joint (the "SI Joint"). The Company has developed The Catamaran™ SI Joint Fusion System that offers a novel, less invasive approach to the SI Joint using a single, robust titanium implant. In August 2025, the Company acquired substantially all of the assets of SiVantage, Inc. and SIMPL Medical, LLC, including the SImmetry+® SI Joint Fusion System, which treats disorders of the SI Joint through a minimally invasive lateral access solution that incorporates well-established orthopedic fusion principles. Since the national launch of The Catamaran System in October 2022, Tenon is focused on three commercial opportunities: 1) primary SI Joint procedures, 2) revision procedures of failed SI Joint implants and 3) SI-Joint fusion adjunct to a spine fusion construct.
For more information, please visit www.tenonmed.com. Information on the Company's website does not constitute a part of and is not incorporated by reference into this press release.
The Tenon Medical logo shown above, and Catamaran®, PiSIF®, CAT PiSIF®, ETAD®, Posterior Inferior Sacroiliac Fusion®, CAT SIJ Fusion System®, Catamaran SIJ Fusion System®, Catamaran Inferior Posterior Fusion System®, Catamaran Transfixation Fusion System®, Catamaran Transfixation Fusion Device®, SImmetry® are registered trademarks of Tenon Medical, Inc. MAINSAILTM, and SImmetry+ are also trademarks of Tenon Medical, Inc.
Safe Harbor
This press release contains "forward-looking statements," which are statements related to events, results, activities or developments that Tenon expects, believes or anticipates will or may occur in the future. Forward-looking often contains words such as "intends," "estimates," "anticipates," "hopes," "projects," "plans," "expects," "seek," "believes," "see," "should," "will," "would," "target," and similar expressions and the negative versions thereof. These forward-looking statements, include, but are not limited to, statements regarding the completion of the Offering, the satisfaction of customary closing conditions related to the Offering and the anticipated use of proceeds therefrom. Such statements are based on Tenon's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances, and speak only as of the date made. Forward-looking statements are inherently uncertain and actual results may differ materially from assumptions, estimates or expectations reflected or contained in the forward-looking statements as a result of various factors. For details on the uncertainties that may cause Tenon's actual results to be materially different than those expressed in any forward-looking statements, please review Tenon's Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and updated from time to time in our Form 10-Q filings and in our other public filings on file with the SEC at www.sec.gov statements contain, particularly the information contained in the section entitled "Risk Factors." We undertake no obligation to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law.
IR Contact:
Shannon Devine
203-741-8811
MZ North America
tenon@mzgroup.us
SOURCE: Tenon Medical, Inc.
View the original press release on ACCESS Newswire