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Shoulder Innovations Receives FDA 510(k) Clearance for N-22 Humeral Head
Shoulder Innovations announced it has received U.S. FDA 510(k) clearance for the N-22 Humeral Head, a titanium implant option for patients with metal hypersensitivity. Alongside the clearance, the company also announced the product's full commercial launch. Approximately 10% to 15% of the general population test positively for metal hypersensitivity and may experience persistent pain, or other symptoms associated with allergic reactions from metal implants. The N-22 Humeral Head is designed for use in anatomic total shoulder arthroplasty procedures involving patients with these complications and complements the company's N-22 Glenosphere implant, cleared in January 2026, which is used in reverse total shoulder arthroplasty procedures involving the same patient population.
Shoulder Innovations Enters Exclusive Collaboration with ALM Ortho
Shoulder Innovations has entered into an exclusive collaboration with ALM Ortho, which deals in additive manufacturing of titanium orthopedic implants, to introduce a bespoke implant for the treatment of severe shoulder deformity and other highly complex revision cases, circumstances for which no adequate solution currently exists. Informed by patient imaging data, ALM Ortho's implants are designed on a case-by-case basis, personalized to individual patient needs and anatomy, and delivered to surgical teams for implantation. Under the collaboration agreement, Shoulder Innovations holds exclusive rights for upper extremity applications of ALM Ortho's solutions in the United States. Shoulder Innovations will leverage its existing ecosystem to identify appropriate cases and connect surgeons and facilities with the ALM Ortho solution, while ALM Ortho will design, manufacture, and deliver these devices to surgeons. Specific financial terms of the agreement are confidential.
Shoulder Innovations Settles Patent Litigation with Catalyst OrthoScience
Shoulder Innovations announced that it has entered into a settlement agreement with Catalyst OrthoScience to resolve all outstanding patent litigation between the two companies. The terms of the settlement agreement are confidential.
Shoulder Innovations Appoints Jon Osborne as Chief Commercial Officer
Shoulder Innovations announced the promotion of Jon Osborne to Chief Commercial Officer, effective August 6. Osborne, who most recently served as VP of Commercial Development, will now have responsibility for all elements of Shoulder Innovations' commercial organization. Prior to joining Shoulder Innovations as VP of Commercial Development in September 2023, Osborne held several positions of increasing responsibility from 2014 to 2023 at Smith & Nephew, most recently as VP of Commercial Marketing for the Sports Medicine business in the Americas. Earlier in his career at Smith & Nephew, he also served as an Area Vice President of Sales and as Director of Global Marketing, where he launched products and built distribution across six continents. Prior to Smith & Nephew, Osborne worked in sales management, global marketing, and general management from 1998 to 2014 in both domestic and international markets at ArthroCare Corporation, Tornier USA, and Team Surgical.
Shoulder Innovations Files $300M Mixed Securities Shelf
Shoulder Innovations files $300M mixed securities shelf
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