SINEFIX— 510(k) K254176

Name: FDA 510(k) clearance K254176
Creator: U.S. Food and Drug Administration
Published: 2026-03-16

Substantially Equivalent

BAAT Medical Products B.V.

FDA 510(k) clearance K254176 for SINEFIX, Substantially Equivalent on 2026-03-16. Applicant: BAAT Medical Products B.V.. Device class: 2.

Summary

BAAT Medical Products' SINEFIX is filed under MBI, nondegradable soft tissue fixation fasteners. The record gives only that one-word name, with no sizes or models.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).

BAAT Medical Products filed from Hengelo, the Netherlands. Review took 83 calendar days (December 23, 2025 to March 16, 2026).

Clearance details

Applicant: BAAT Medical Products B.V.
Product code: Product code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2025-12-23
Decision date: 2026-03-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Hengelo, NL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.