~[24~R Direct Current Bone Growth Stimulator
by Zimmer, Inc. PMA
Active
PMA P790008
Overview
The 24R Direct Current Bone Growth Stimulator is an invasive bone growth stimulator, classified as a Class III medical device under FDA regulations. It is designed to promote bone healing and growth through the application of direct current stimulation, aiding in the treatment of nonunion fractures or delayed bone healing in orthopedic applications.
This device is supplied as a reusable medical instrument, intended for use in clinical settings such as orthopedic surgery or rehabilitation facilities. It requires FDA PMA authorization (PMA Number: P790008) and has undergone regulatory supplements for design or component changes. The stimulator is not labeled as MRI-safe, and proper storage and handling per manufacturer guidelines are essential to maintain functionality and sterility.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP790008 | Date29 Mar 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Generic Name
- Stimulator, invasive bone growth
- PMA Number
- FDA Product Code
- LOE
- Device Class
- Class III
- Advisory Committee
- Orthopedic
- FDA Decision
- APPR Approved
- PMA Supplement
- S005 (Normal 180 Day Track)
Other devices from Zimmer, Inc.
Questions
What types of clinical settings is the 24R Direct Current Bone Growth Stimulator intended for use in, and why is this important?
The **24R Direct Current Bone Growth Stimulator** is designed for use in **clinical settings such as orthopedic surgery or rehabilitation facilities**, as it is classified as a reusable medical instrument. This distinction is important because it ensures the device is maintained in controlled environments where proper sterilization and handling protocols can be consistently followed, reducing infection risks and maintaining device integrity for repeated use.
Is this device safe for use in MRI environments, and what should clinicians consider if MRI scans are needed for the patient?
The **24R Direct Current Bone Growth Stimulator is not labeled as MRI-safe**, meaning it should not be used in or near MRI machines. Clinicians must ensure the device is removed from the patient before MRI scans are performed to avoid potential interference, damage to the device, or safety hazards. Always follow manufacturer guidelines for proper handling and removal.
How is the 24R Direct Current Bone Growth Stimulator regulated, and what does this mean for purchasing or using the device?
The device requires **FDA Premarket Approval (PMA)** under PMA Number **P790008**, confirming it meets stringent safety and effectiveness standards for Class III medical devices. This means purchasers or users must verify the device’s regulatory status (e.g., approved PMA) before implementation, as it ensures compliance with U.S. medical device laws and reduces legal or operational risks in clinical settings.
What does the term ‘reusable’ mean for this device, and how should it be maintained to ensure proper functionality?
As a **reusable medical instrument**, the **24R Direct Current Bone Growth Stimulator** is intended for multiple uses in clinical settings, provided it undergoes proper cleaning, sterilization, and maintenance per manufacturer guidelines. This classification emphasizes the need for strict adherence to infection control protocols and regular inspections to preserve functionality, sterility, and performance over repeated use cycles.
What should buyers or clinicians know about the regulatory history of this device, particularly regarding design changes?
The device has undergone **regulatory supplements (e.g., S005)** for changes in design, components, specifications, or materials, which were reviewed under a **Normal 180-Day Track** process. Buyers should confirm the latest approved version (e.g., supplement number) with the manufacturer or regulatory records to ensure they are using a compliant, up-to-date model, as unapproved modifications could impact safety or efficacy.