← Back to catalogue

AccuStride System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252064

by Medcad

Identifiers

510(k) Number
K252064 FDA 510(k)
FDA Product Code
PBF 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 AccuStride System is a patient-specific orthopedic surgical planning and instrument guide, classified as a Class II device under FDA regulations. It is designed to assist in preoperative planning and intraoperative guidance for non-acute, non-joint replacing osteotomies in the foot, ankle, tibia, and fibula, serving both adult and pediatric patients aged 12 and older.

This system is supplied as a reusable set of surgical guides and anatomical models, intended for use in orthopedic procedures. It is not sterile upon delivery and must be sterilized prior to use. The device is authorized under FDA 510(k) clearance (K252064) and falls under the regulatory category of PBF (Product Classification Branch). No specific MRI safety information is provided in the data.

Frequently asked questions

What types of orthopedic procedures is the MedCAD® AccuStride™ System designed to assist with, and what age groups can use it?

The MedCAD® AccuStride™ System is specifically designed to assist in preoperative planning and intraoperative guidance for non-acute, non-joint replacing osteotomies in the foot, ankle, tibia, and fibula. It is intended for both adult and pediatric patients aged 12 and older, ensuring versatility across a range of orthopedic cases.

Is the MedCAD® AccuStride™ System sterile when received, and what preparation is required before use?

No, the MedCAD® AccuStride™ System is not sterile upon delivery. It is supplied as a reusable set of surgical guides and anatomical models, so it must be sterilized prior to use in any procedure. Sterilization is the responsibility of the facility using the device.

How is the MedCAD® AccuStride™ System regulated by the FDA, and what does this mean for its use in clinical settings?

The MedCAD® AccuStride™ System is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance (K252064). This means it has been reviewed and determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for use in orthopedic surgical planning and intraoperative guidance.

Are there multiple models or sizes available for the MedCAD® AccuStride™ System, and how does this affect its applicability?

The system includes multiple anatomical models and surgical guides, as indicated by the diverse registration numbers (e.g., 3027329005, 3014273501, etc.), which correspond to different components or variations tailored for various orthopedic procedures in the foot, ankle, tibia, and fibula. This variety ensures the system can be adapted to a wide range of patient anatomies and surgical needs.

What should clinicians consider regarding the storage and handling of the MedCAD® AccuStride™ System between uses?

Since the system is reusable, clinicians must follow proper sterilization protocols after each use to maintain its integrity and safety. Storage should be in a clean, dry environment, protected from physical damage or contamination, to ensure the guides and models remain accurate and functional for future procedures. Always refer to the manufacturer’s instructions for specific storage guidelines.

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: AccuStride® Foot + Ankle System for Lower Extremity Reconstruction - MedCAD, MedCAD's AccuStride Fixation Plates FDA Clearance, MedCAD® AccuStride™ System (K252064) — FDA 510(k) | Innolitics, MedCAD® AccuStride™ System (K251709) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medcad

Sources (1)

  • FDA 510(k) K252064 24 fields · synced Sep 19, 2026