Cleared Traditional

K254188 - Meniscus Versaflex (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K254188 · GM Dos Reis Industria e Comercio Ltda. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
58d
Days
Class 2
Risk

K254188 is an FDA 510(k) clearance for the Meniscus Versaflex. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on February 19, 2026 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.5000 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GM Dos Reis Industria e Comercio Ltda. devices

Submission Details

510(k) Number K254188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 122d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 172
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K254188.
HyperSuture All Green Extension Line
K254275 · Threadstone, LLC · Mar 2026
Pre-Sutured Tendon
K253145 · Rti Surgical, Inc. · Oct 2025
ProZip Knotless Implant
K253024 · Riverpoint Medical · Oct 2025
PowerKnot High Strength Sutures
K252225 · Medacta International S.A. · Sep 2025
HS Fiber
K252201 · Riverpoint Medical · Aug 2025
HyperSuture White/Green Extension Line
K242201 · Threadstone, LLC · Mar 2025