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Precice Unyte System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172061

by Nuvasive Specialized Orthopedics, Inc.

Identifiers

510(k) Number
K172061 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 Unyte System is a magnetically controlled internal fixation device designed for limb lengthening and fracture management of the humerus. It employs distraction osteogenesis to gradually lengthen bone or consolidate fractures through non-invasive adjustments. The system integrates an intramedullary nail with a remote control for precise, external modulation of bone alignment.

This device is supplied as a reusable surgical implant system, intended for use in orthopedic procedures under sterile conditions. It is regulated under FDA 510(k) clearance (K172061) and falls under the product code HSB for orthopedic fixation devices. The system requires specialized training for application and is not MRI-compatible. Storage and handling must adhere to manufacturer guidelines for orthopedic implants.

Frequently asked questions

What types of bone procedures is the Precice Unyte System specifically designed for, and how does it work?

The Precice Unyte System is designed for limb lengthening and fracture management of the humerus only. It uses distraction osteogenesis, a process where a small gap is created in the bone and gradually widened under controlled conditions to encourage new bone growth. The system includes an intramedullary nail implanted inside the bone, which is adjusted externally via a remote control to precisely modulate bone alignment without invasive surgery.

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

The Precice Unyte System is explicitly described as a reusable surgical implant system. This means it is engineered for repeated use in different patients, provided it is properly cleaned, sterilized, and maintained according to the manufacturer’s guidelines for orthopedic implants.

What precautions should be taken when storing or handling the Precice Unyte System?

The system must be stored and handled under sterile conditions, as required for orthopedic implants. Since it is reusable, adherence to strict cleaning and sterilization protocols is critical to prevent contamination between uses. The manufacturer’s guidelines for orthopedic implants should be followed to ensure proper storage, handling, and maintenance.

Can the Precice Unyte System be used in MRI scans, and why?

No, the Precice Unyte System is not MRI-compatible. This is because the magnetic components of the device could interact with MRI machines, potentially causing interference, displacement, or heating of the implant. Patients using this system should avoid MRI procedures unless specifically cleared by their physician.

What kind of training is required to use the Precice Unyte System, and who should perform the procedure?

The Precice Unyte System requires specialized training for proper application. Given its complexity—particularly the need for precise external adjustments via the remote control—it should be used by orthopedic surgeons or clinicians with advanced training in limb lengthening and distraction osteogenesis techniques. Training ensures safe implantation, adjustment, and post-operative management.

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: Precice™ | Globus Medical - NuVasive, PDF PRECICE UNYTE Humeral Nail - s3.amazonaws.com, UPDATE: NuVasive Specialized Orthopedics' Precice Devices - Letter to ...

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) K172061 24 fields · synced Sep 20, 2026