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Precice Stryde System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180503

by Nuvasive Specialized Orthopedics, Inc.

Identifiers

510(k) Number
K180503 FDA 510(k)
FDA Product Code
HSB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3020 FDA 510(k)
Regulation Number
888.3020 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Precice Stryde System is a spinal external fixation device designed for limb lengthening and compression treatment. It is classified as an orthopedic external fixation system, providing controlled distraction and compression to correct limb deformities or achieve lengthening. The system is intended for use in orthopedic procedures where gradual bone elongation or alignment adjustment is required. Its design supports minimally invasive techniques, reducing surgical intervention while maintaining therapeutic outcomes.

The Precice Stryde System is supplied as a reusable medical device, intended for use in clinical settings such as orthopedic clinics or surgical centers. It is regulated under FDA 510(k) clearance (K180503) as substantially equivalent to existing orthopedic devices, with approval categorized under the Orthopedic (OR) advisory committee. The system is not described as single-use, and no specific sterility or MRI safety information is provided in the available data. Storage and handling instructions are not detailed, but compliance with standard orthopedic device protocols is implied.

Frequently asked questions

What types of limb corrections or procedures is the Precice Stryde System designed to assist with?

The Precice Stryde System is specifically designed for spinal external fixation to address limb lengthening and compression treatments. It is used in orthopedic procedures where controlled distraction or compression is required to gradually correct limb deformities or achieve targeted bone elongation. This makes it suitable for cases involving congenital limb discrepancies, post-traumatic deformities, or other conditions requiring gradual alignment adjustments.

Is the Precice Stryde System intended for single-use or can it be reused in multiple procedures?

The Precice Stryde System is explicitly described as a reusable medical device, intended for use in clinical settings like orthopedic clinics or surgical centers. This means it is engineered to withstand repeated sterilization and use across multiple patients, reducing costs and waste compared to single-use alternatives.

How is the Precice Stryde System regulated, and what does its FDA clearance status mean for clinicians?

The Precice Stryde System holds an FDA 510(k) clearance (K180503), classified as substantially equivalent to existing orthopedic external fixation devices. This clearance was reviewed under the Orthopedic (OR) Advisory Committee and falls under the Special 510(k) pathway, indicating a thorough evaluation of its safety and effectiveness. Clinicians can rely on this status as evidence of regulatory scrutiny, though they should always follow facility protocols and manufacturer guidelines for proper use.

What clinical environments or settings is the Precice Stryde System intended for, and how is it typically supplied?

The system is designed for use in clinical settings such as orthopedic clinics or surgical centers, where controlled limb lengthening or compression is performed. It is supplied as a reusable device, meaning it is intended for repeated use after proper cleaning and sterilization between procedures. The manufacturer implies adherence to standard orthopedic device protocols for storage and handling, though specific instructions are not detailed in the available data.

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: NuVasive PRECICE STRYDE™ System Used In First Patient For Stature ..., Precice™ | Globus Medical - NuVasive, PDF The Futur e of Limb Lengthening and Compression Treatment - NuVasive

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nuvasive Specialized Orthopedics, Inc.

Sources (1)

  • FDA 510(k) K180503 24 fields · synced Sep 20, 2026