đź“‹ FDA Reference
Quicklock Orthopaedic Targeting System
Rdh Medical
Summary: The Quicklock Orthopaedic Targeting System is a medical device used in orthopedic surgeries to assist in the precise placement of implants. It is primarily used by orthopedic surgeons in surgical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K964444 ↗
Decision Date ?
August 11, 1997
Product Code ?
HSB
Device Class ?
Class 2
Evidence ?
0 studies
The Quicklock Orthopaedic Targeting System was cleared through the FDA 510(k) pathway on August 11, 1997. It is manufactured by Rdh Medical and classified as a Class 2 device.
What It Is
The Quicklock Orthopaedic Targeting System is designed to aid orthopedic surgeons in accurately targeting and placing implants during surgical procedures. It provides a reliable framework that enhances precision, reducing the risk of misalignment. This system is particularly useful in complex orthopedic surgeries where precision is critical for successful outcomes.
FDA-Cleared Indications
- Intended to assist with the targeting and placement of orthopedic implants during orthopedic surgical procedures, according to its FDA 510(k) classification and product code HSB.
- Use is limited to the procedures, implant systems, instruments, and patient populations described in the manufacturer’s current labeling.
Clinical Applications
- Assisting orthopedic surgeons with accurate implant targeting during orthopedic surgery.
- Supporting controlled placement of fixation hardware during procedures in which the system is included in the cleared surgical technique.
- Helping guide implant positioning in an operating-room setting when precise alignment is required.
Practical Considerations
- The available FDA record provides limited indication detail; the manufacturer’s instructions for use should be checked before identifying a specific implant, procedure, or anatomy as on-label.
- The system may include components in different sizes or configurations; selection depends on the surgical technique, implant system, and patient anatomy.
- Compatibility with other orthopedic instruments and implants must be confirmed from the manufacturer’s labeling. Components should not be substituted unless compatibility is established.
- This is a surgical targeting system rather than an implant intended to remain in the body. MRI safety depends on whether any component is retained and on the materials and labeling for that component.
- Use requires trained orthopedic surgical personnel, appropriate sterile handling, and inspection for damage or loss of alignment before use.
Frequently Asked Questions
What is the Quicklock Orthopaedic Targeting System used for?
It is used to assist in the precise placement of orthopedic implants during surgeries.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise targeting and placement of orthopedic implants, such as joint replacements and fracture repairs.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.