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TriLEAP Plating System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230591

by Crossroads Extremity Systems

Identifiers

510(k) Number
K230591 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 TriLEAP Plating System is an orthopedic fixation device classified as a Lower Extremity Anatomic Plating System, designed for the reduction, temporary fixation, fusion, and stabilization of bones in the foot and ankle. It comprises a range of non-contoured and anatomically contoured plates (2.0mm, 2.5mm, 3.0mm, 3.5mm, and 4.0mm), cortical screws, variable-angle locking screws, and Jones screws, tailored for procedure-specific applications.

This system is supplied in a non-sterile state and requires reprocessing by a third-party facility to achieve sterility before use. It is intended for single-patient use and must be handled in accordance with sterile surgical protocols. The device is regulated under the FDA’s 510(k) clearance (K230591) and is intended for use in orthopedic procedures within the lower extremity, adhering to MRI safety guidelines for metallic implants. Storage and handling must comply with manufacturer instructions to maintain integrity.

Frequently asked questions

What types of orthopedic procedures is the TriLEAP Plating System specifically designed for in the foot and ankle?

The TriLEAP Plating System is designed for reduction, temporary fixation, fusion, and stabilization of bones in the foot and ankle. It includes non-contoured and anatomically contoured plates (ranging from 2.0mm to 4.0mm) along with cortical screws, variable-angle locking screws, and Jones screws, all tailored for procedure-specific applications in lower extremity orthopedic surgery.

How is the TriLEAP Plating System supplied, and what steps are required to make it sterile before use?

The TriLEAP Plating System is supplied in a non-sterile state and must be reprocessed by a third-party facility to achieve sterility before surgical use. After reprocessing, it must be handled under sterile surgical protocols as a single-patient-use device.

Can this device be reused, and if not, what are the implications for surgical planning?

The TriLEAP Plating System is intended for single-patient use only. This means each component must be dedicated to one surgical procedure, requiring careful inventory management and planning to ensure availability for each case.

What size variations are available for the plates in the TriLEAP Plating System, and how might this affect my choice of fixation?

The system offers plates in five thickness variations: 2.0mm, 2.5mm, 3.0mm, 3.5mm, and 4.0mm, including both non-contoured and anatomically contoured options. The choice of plate thickness and contouring depends on the specific anatomical requirements of the patient’s foot or ankle, ensuring optimal stability and fixation during orthopedic procedures.

Are there any special considerations for storage or handling of the TriLEAP Plating System to maintain its integrity?

Yes, storage and handling of the TriLEAP Plating System must strictly follow the manufacturer’s instructions to preserve its integrity. Since it is non-sterile until reprocessed, it should be stored in a clean, dry environment away from contaminants until ready for third-party sterilization. After sterilization, it must be handled as a sterile device under surgical protocols.

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: TriLEAP™ Lower Extremity Anatomic Plating System, PDF ENGLISH INSTRUCTIONS FOR USE TRILEAP Lower Extremity Anatomic Plating ..., PDF ENGLISH INSTRUCTIONS FOR USE TRILEAP Lower Extremity Anatomic Plating ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Crossroads Extremity Systems

Sources (1)

  • FDA 510(k) K230591 24 fields · synced Sep 19, 2026