Cleared Traditional

Shoulder Soft Tissue Anchors

K242477 · Signature Orthopaedics Pty, Ltd. · Orthopedic
May 2025
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K242477 is an FDA 510(k) clearance for the Shoulder Soft Tissue Anchors, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on May 12, 2025, 264 days after receiving the submission on August 21, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K242477 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2024
Decision Date May 12, 2025
Days to Decision 264 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040