510(k) K242477

Shoulder Soft Tissue Anchors by Signature Orthopaedics Pty, Ltd. — Product Code MBI

K242477 is an FDA 510(k) premarket notification submitted by Signature Orthopaedics Pty, Ltd. for the device "Shoulder Soft Tissue Anchors". The FDA issued a decision of Substantially Equivalent on May 12, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Signature Orthopaedics Pty, Ltd. has at least 10 other 510(k) clearances on record.