Knotilus+ Biocomposite Knotless Anchor— 510(k) K250544

Substantially Equivalent

Stryker Endoscopy

FDA 510(k) clearance K250544 for Knotilus+ Biocomposite Knotless Anchor, Substantially Equivalent on 2025-05-23. Applicant: Stryker Endoscopy.

Clearance details

Applicant: Stryker Endoscopy
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2025-02-25
Decision date: 2025-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.