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 ?
510(k)
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.
FDA-Cleared Indications
- Intended for surgical removal of bone or cartilage.
- Used during orthopedic and spinal surgical procedures requiring tissue scraping or debridement.
Clinical Applications
- Removal of bone or cartilage during orthopedic surgery.
- Removal of bone or cartilage during spinal surgery.
- Surgical debridement where controlled scraping of tissue is required.
- Preparation of an orthopedic or spinal surgical site for additional surgical treatment.
Practical Considerations
- Available in different sizes and configurations; the surgeon selects the instrument based on the anatomy and procedure.
- The looped cutting edge requires controlled handling to avoid unintended tissue injury.
- Use follows standard surgical instrument cleaning, sterilization, inspection, and maintenance procedures according to the manufacturer’s instructions.
- The FDA record does not establish MRI safety; MRI compatibility depends on the specific instrument’s materials and labeling.
- The device is a surgical instrument, not an implant, and should be used only by appropriately trained surgical personnel.
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.