Anchor with Fiber Wire and Disposable Inserter— 510(k) K253027

Name: FDA 510(k) clearance K253027
Creator: U.S. Food and Drug Administration
Published: 2026-05-06

Substantially Equivalent

Ortobio S.A.

FDA 510(k) clearance K253027 for Anchor with Fiber Wire and Disposable Inserter, Substantially Equivalent on 2026-05-06. Applicant: Ortobio S.A.. Device class: 2.

Summary

Ortobio's Anchor with Fiber Wire and Disposable Inserter is filed under MBI, nondegradable soft tissue fixation fasteners. The device name is generic.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).

Ortobio filed from Maringá, Brazil. Review took 229 calendar days (September 19, 2025 to May 6, 2026).

Clearance details

Applicant: Ortobio S.A.
Product code: Product code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2025-09-19
Decision date: 2026-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maringá, BR

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBI

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K263348 — Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue +5 more2026-10-23
K263352 — TeKBrace Knotless Anchor2026-10-21
K261869 — Integrity Retractable Implant Inserter (6000127)2026-09-17
K253065 — Aevumed SUPERCYNCH Button System2026-09-02

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.