đź“‹ FDA Reference
orthopaedic and spinal ring currettes
Karlin Technology
Summary: Orthopaedic and spinal ring curettes by Karlin Technology are surgical instruments used for scraping or debriding biological tissue. They are primarily used by orthopedic and spinal surgeons during procedures involving bone or cartilage.
FDA Clearance Information
Pathway
510K
Number
K882072 ↗
Decision Date
June 17, 1988
Product Code
JXH
Device Class
Class 2
Evidence
0 studies
The orthopaedic and spinal ring curettes by Karlin Technology were cleared through the FDA 510(k) pathway on June 17, 1988. The device is classified as Class 2 under product code JXH.
What It Is
Orthopaedic and spinal ring curettes are specialized surgical instruments designed for the removal of bone or cartilage. They feature a looped, sharp-edged tip that allows for precise scraping and debridement. These instruments are essential in orthopedic and spinal surgeries where meticulous removal of tissue is required to prepare the site for further surgical intervention.
Clinical Applications
These curettes are commonly used in orthopedic and spinal surgeries, particularly in procedures involving the removal of bone spurs, cartilage, or other tissue. They are utilized in settings such as hospitals and specialized surgical centers by orthopedic surgeons, spinal surgeons, and sometimes neurosurgeons. Patients undergoing procedures for conditions like spinal stenosis or joint arthroplasty may benefit from the use of these curettes.
Indications for Use
The FDA indications suggest that these curettes are intended for use in surgical procedures requiring the removal of bone or cartilage. They are suitable for patients undergoing orthopedic or spinal surgeries where precise tissue debridement is necessary.
Practical Considerations
These curettes come in various sizes to accommodate different surgical needs and anatomical areas. They are compatible with standard surgical techniques and require careful handling to ensure precision and safety during tissue removal. Surgeons should select the appropriate size based on the specific procedure and patient anatomy.
Frequently Asked Questions
What is orthopaedic and spinal ring curettes used for?
They are used for scraping or debriding bone and cartilage during orthopedic and spinal surgeries.
What specialties typically use this device?
Orthopedic surgeons, spinal surgeons, and sometimes neurosurgeons typically use these curettes.
What are the FDA-cleared indications?
They are indicated for use in surgical procedures requiring the removal of bone or cartilage.
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.