Fuse Medical, Inc. Announces FDA 510(k) Clearance of the Sterizo™ Tibial Revision Knee System and PS Plus Posterior Stabilized Tibial Insert

Rhea-AI Summary

Fuse Medical, Inc. (OTCPINK: FZMD) has received FDA 510(k) clearance for its Tibial Revision Knee System and PS Plus Posterior Stabilized Tibial Insert, enhancing the Sterizo™ Total Knee System. These innovations provide surgeons with improved options for patients requiring greater anatomical support. The Tibial Revision System is designed for higher BMI patients and aims to expand market reach. CEO Christopher C. Reeg emphasized the commitment to innovative solutions for clinical challenges, supporting the company's growth and development efforts in the orthopedic sector.

Positive

• FDA clearance for Tibial Revision Knee System and PS Plus Posterior Stabilized Tibial Insert.
• Enhancements to the Sterizo™ Total Knee System increase options for surgeons and patients.
• Broader market targeting and potential for new sales channels.
• Commitment to developing innovative solutions for clinical challenges.

Negative

• None.

RICHARDSON, Texas--(BUSINESS WIRE)-- Fuse Medical, Inc. (OTCPINK: FZMD) (“Fuse” or the “Company”), an emerging manufacturer and distributor of innovative medical devices for the orthopedic and spine marketplace, announced today it had received its latest U.S. Food and Drug Administration (“FDA”) 510(k) clearance for the Company’s Tibial Revision Knee System, and the PS Plus Posterior Stabilized Tibial Insert, the latest additions to the Sterizo™ Total Knee System.

The Sterizo™ Tibial Revision Knee System provides the surgeon a stemmed option in a primary total knee arthroplasty for patients with higher Body Mass Index (BMI) or requiring additional stability, as well as tibial augments to address anatomical defects. The Tibial Revision Knee System is the basis for the Sterizo™ Total Revision Knee System, which is currently under development and slated for initial launch in late 2022. The Sterizo™ Total Revision Knee System will be fully compatible with the Sterizo™ Primary Total Knee System and offer a full range of femoral and tibial stems, offsets, and augments.

The Sterizo™ PS Plus Posterior Stabilized Tibial Insert provides increased varus/valgus constraint and limits internal/external rotation as compared to the standard Sterizio™ Posterior Stabilized Tibial Insert, accomodating patients that require more constraint. This product line extension will complement the offerings currently available with the High Flexion engineered Sterizo™ Primary Total Knee System, which include Cruciate Retained, Ultra Congruent/Anterior Stabilized, and Posterior Stabilized options.

Christopher C. Reeg, Chief Executive Officer of Fuse commented, “With our Sterizo™ Tibial Revision Knee System cleared for use in primary applications, we can now offer the additional options surgeons may need to meet specific patient anatomy requirements. The expansion of offerings for our Sterizo™ Total Knee System demonstrates our continued commitment to develop and expand our portfolio of Fuse manufactured medical device products.

“Adding these new options to the already robust Sterizo™ platform allows us to better target new distribution and sales channels. These new products, along with our future product development pipeline, will also assist in attracting experienced sales professionals in our industry.”

Reeg further stated, “Our priority at Fuse remains to provide innovative solutions for today’s clinical challenges and assist with improving surgical outcomes.”

About Fuse Medical, Inc.

Fuse is an emerging manufacturer and distributor of innovative medical devices for the orthopedic and spine marketplace committed to the advancement of anatomical motion, preservation and restoration. We provide a comprehensive portfolio of products in the orthopedic total joints, sports medicine, trauma, foot and ankle space, as well as, degenerative and deformity spine, orthobiologics and regenerative products. For more information about Fuse, or if you’re interested in becoming a distributor of the Sterizo™ Total Knee System or any of Fuse’s products, please contact us at info@fusemedical.com or visit: www.fusemedical.com.

Forward Looking Statements

Certain statements in this press release, constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend,” or similar expressions or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based only on information available to the Company as of the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the Securities and Exchange Commission; the failure of the Company to close the transaction; and integration issues with the consolidated company. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events, or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210826005263/en/

Fuse Medical, Inc.

Devon Morgan, Sr. Investor Relations Analyst

Office (469) 862-3030

Facsimile (469) 862-3035

info@Fusemedical.com

Source: Fuse Medical, Inc.

FAQ

What new products did Fuse Medical announce with FDA clearance on October 2023?

Fuse Medical announced FDA clearance for its Tibial Revision Knee System and PS Plus Posterior Stabilized Tibial Insert.

How do the new products affect Fuse Medical's market position?

The new products enhance Fuse Medical's Sterizo™ Total Knee System, allowing better targeting of distribution and sales channels.

What are the features of the Tibial Revision Knee System from Fuse Medical?

The Tibial Revision Knee System offers stemmed options for patients with higher BMI and anatomical defects.

When is the initial launch of the Sterizo™ Total Revision Knee System planned?

The Sterizo™ Total Revision Knee System is slated for initial launch in late 2022.

What does Fuse Medical aim to achieve with its new product developments?

Fuse Medical aims to provide innovative solutions for clinical challenges and improve surgical outcomes.