Cleared Traditional

Knotilus+ Biocomposite Knotless Anchor

K250544 · Stryker Endoscopy · Orthopedic
May 2025
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K250544 is an FDA 510(k) clearance for the Knotilus+ Biocomposite Knotless Anchor, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on May 23, 2025, 87 days after receiving the submission on February 25, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K250544 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2025
Decision Date May 23, 2025
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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