Cleared Traditional

K252664 - GMReis Suture Anchors

K252664 is the FDA 510(k) clearance for GMReis Suture Anchors by GM Dos Reis Industria e Comercio Ltda.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K252664 · GM Dos Reis Industria e Comercio Ltda. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
74d
Days
Class 2
Risk

K252664 is an FDA 510(k) clearance for the GMReis Suture Anchors. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on November 4, 2025 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 K252664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2025
Decision Date November 04, 2025
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 412
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K252664.
QuadLock™ Fixation System
K253618 · Abanza Tecnomed S.L · Jan 2026
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
K253895 · Arthrex, Inc. · Dec 2025
Tigon Medical Knotless and Dual Javelin All-Suture Anchors
K252596 · Tigon Medical · Dec 2025
Arthrex SutureTak Suture Anchor
K252314 · Arthrex, Inc. · Oct 2025
Aevumed FASE Suture Anchor
K253040 · Aevumed, Inc. · Oct 2025
Mini Superhawk Suture Anchor System
K253010 · Responsive Arthroscopy, LLC · Oct 2025