Cleared Traditional

Meniscus Versaflex

K254188 · GM Dos Reis Industria e Comercio Ltda. · Orthopedic
Feb 2026
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K254188 is an FDA 510(k) clearance for the Meniscus Versaflex, a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on February 19, 2026, 58 days after receiving the submission on December 23, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K254188 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2025
Decision Date February 19, 2026
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5000