Precice Intramedullary Limb Lengthening System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220234 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 Intramedullary Limb Lengthening System is an orthopedic device classified as an intramedullary nail for limb lengthening and bone reconstruction. It is designed to address conditions such as nonunions, malunions, pseudarthrosis, and bone transport in long bones, including the femur and tibia. The system facilitates controlled lengthening and stabilization of bone segments through an internal, motorized mechanism. Its application extends to both adult and pediatric patients (aged 12 and older) for fracture fixation and limb length correction.
The device is supplied as a reusable surgical implant and is intended for use in orthopedic procedures performed in clinical settings. It is not MRI-safe and requires sterile handling and proper storage as per manufacturer guidelines. The system is authorized under FDA 510(k) clearance (K220234) for traditional review in the Orthopedic advisory committee category. No third-party review was involved in its regulatory clearance.
Frequently asked questions
What conditions is the Precice Intramedullary Limb Lengthening System designed to treat?
The Precice System is specifically engineered to address complex bone healing challenges, including nonunions (failed bone healing), malunions (poorly healed fractures), pseudarthrosis (false joints), and bone transport procedures. It is also used for limb length correction in both adult and pediatric patients aged 12 and older, providing a controlled, internal method for gradual bone elongation and stabilization during fracture fixation.
How is the Precice System supplied and what are its key usage requirements?
The Precice Intramedullary Limb Lengthening System is supplied as a reusable surgical implant, intended exclusively for clinical use in orthopedic procedures. It requires sterile handling and adherence to manufacturer guidelines for storage to maintain integrity. Unlike disposable devices, it is designed for repeated use within approved clinical settings, ensuring durability and reliability for prolonged limb lengthening applications.
Is the Precice System safe for MRI procedures, and what precautions should be taken during use?
The Precice Intramedullary Limb Lengthening System is not MRI-safe, meaning it should never be exposed to MRI environments due to potential interference or safety risks. Clinicians must confirm the absence of MRI procedures for patients with this device implanted and follow strict sterile protocols during surgery and post-operative care to prevent contamination or infection.
What distinguishes the Precice System from other intramedullary nails in terms of functionality?
Unlike traditional intramedullary nails, the Precice System incorporates an internal, motorized mechanism that enables precise, controlled lengthening of bone segments without external hardware. This design eliminates the need for external fixation devices (e.g., rings or wires) while maintaining stability, reducing patient discomfort and improving compliance during the lengthening process.
Are there specific storage or handling guidelines for the Precice System after surgery?
Post-surgery, the Precice System must be stored in a sterile, protected environment as directed by the manufacturer to prevent damage or contamination. Since it is reusable, it should be cleaned and prepared for reuse according to established protocols, ensuring compatibility with subsequent procedures. Proper storage also involves securing the device to avoid physical stress or bending, which could compromise its functionality.
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, NuVasive Specialized Orthopedics, Inc., Limb Lengthening and Reconstruction | Globus Medical - NuVasive
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220234 | Class II | Active |
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Manufacturer
- Manufacturer
- Nuvasive Specialized Orthopedics, Inc.
Sources (1)
- FDA 510(k) K220234 24 fields · synced Oct 1, 2026