Cleared Special

K262537 - Versalock Sterile Plating System

K262537 is an FDA 510(k) clearance for Versalock Sterile Plating System, manufactured by GM Dos Reis Industria e Comercio Ltda.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 27-day FDA review.

K262537 · GM Dos Reis Industria e Comercio Ltda. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
27d
Days
Class 2
Risk

K262537 is an FDA 510(k) clearance for the Versalock Sterile Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on August 19, 2026 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all GM Dos Reis Industria e Comercio Ltda. devices

FDA 510(k) Submission Details - K262537

510(k) Number K262537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2026
Decision Date August 19, 2026
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1073
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K262537.
FRAXION 3.5 Plate System (Various - See Catalog)
K261830 · Ortler Global Tibbi Gerecler Anonim Sirketi · Aug 2026
MIKRON TRAUMA BONE PLATE& SCREW SYSTEM
K260277 · Mikron Makina San. ve Tic. Ltd. Sti. · Aug 2026
Xpert Ankle
K261511 · Newclip Technics · Jul 2026
Versalock Proximal Tibial Plating System
K261406 · GM Dos Reis Industria e Comercio Ltda. · Jul 2026
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD)
K262032 · TriMed, Inc. · Jul 2026
Alians Elbow S
K261191 · Newclip Technics · Jul 2026