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Gridlock Plating System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130964

by Trilliant Surgical LLC

Identifiers

510(k) Number
K130964 FDA 510(k)
FDA Product Code
HRS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Gridlock Plating System is a versatile ankle plating system designed for a range of surgical procedures, including trauma and corrective surgeries. It features low profile, pre-bent, and pre-contoured titanium plates with vanishing edges to minimize post-operative palpability and limited surface contact.

The system includes 2.7, 3.5, and 4.0mm low profile solid core locking and non-locking screws, 4.0mm cannulated screws, and syndesmotic screws with a tapered core. This device is authorized under FDA 510k clearance K130964.

Frequently asked questions

What surgical procedures is the Gridlock Plating System indicated for?

The Gridlock Plating System is designed for a range of ankle surgical procedures, specifically including trauma and corrective surgeries.

What are the key design features of the Gridlock plates?

The plates are manufactured from titanium and feature a low-profile, pre-bent, and pre-contoured design. They also incorporate vanishing edges to minimize post-operative palpability and limited surface contact with the bone.

What types of screws are included in the Gridlock Plating System?

The system includes 2.7, 3.5, and 4.0mm low-profile solid core locking and non-locking screws. Additionally, it provides 4.0mm cannulated screws and syndesmotic screws that feature a tapered core.

What is the regulatory status of the Gridlock Plating System?

The Gridlock Plating System is authorized under FDA 510k clearance K130964, which determined the device to be substantially equivalent to existing predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF DJO TRILLIANT Gridlock Ankle Plating System Instructions, PDF DJO Gridlock Ankle Plating System User Manual, DJO TRILLIANT Gridlock Ankle Plating System Instructions

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Trilliant Surgical LLC
FDA Applicant
Trilliant Surgical, Ltd.

Sources (1)

  • FDA 510(k) K130964 24 fields · synced Sep 21, 2026