đź“‹ FDA Reference
Edwards Orthopaedics Arthroscopes and Accessories
Baxter Healthcare
Summary: The Edwards Orthopaedics Arthroscopes are medical devices used primarily in minimally invasive surgical procedures to visualize joints. They are typically used by orthopedic surgeons in hospital or outpatient settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K880205 ↗
Decision Date ?
February 4, 1988
Product Code ?
HRX
Device Class ?
Class 2
Evidence ?
0 studies
The Edwards Orthopaedics Arthroscopes and Accessories were cleared through the FDA 510(k) pathway on February 4, 1988. Manufactured by Baxter Healthcare, this device is classified as Class 2 under product code HRX.
What It Is
The Edwards Orthopaedics Arthroscopes are specialized instruments designed for arthroscopic procedures, allowing surgeons to view the interior of joints through a small incision. These devices consist of a thin, flexible tube equipped with a camera and light source, providing high-resolution images to aid in diagnosis and treatment. They are essential tools in minimally invasive orthopedic surgeries, reducing recovery time and improving patient outcomes.
FDA-Cleared Indications
- Intended for visualization of the interior of joints during arthroscopic procedures.
- Used with compatible arthroscopic accessories and instruments for diagnosis and treatment of joint conditions.
- Intended for use by trained surgical personnel in appropriate operating-room or outpatient surgical settings.
Clinical Applications
- Arthroscopic visualization of the knee joint
- Arthroscopic visualization of the shoulder joint
- Arthroscopic visualization of the elbow and other accessible joints
- Assessment of suspected cartilage, ligament, synovial, or other intra-articular abnormalities during surgery
- Guidance of arthroscopic treatment performed with compatible surgical instruments
Practical Considerations
- Available configurations and diameters may differ by model and are selected according to the joint, access route, and patient anatomy.
- Use requires compatible light sources, imaging equipment, arthroscopic instruments, and sterile accessories.
- The device must be cleaned, sterilized, inspected, and handled according to the applicable manufacturer instructions and facility protocols.
- MRI safety cannot be determined from the general device category; the specific model and all attached components must be checked for MRI labeling before scanning.
- Use is contraindicated or inappropriate when arthroscopy or anesthesia is unsafe for the patient, or when the device is damaged, contaminated, or incompatible with the surgical system.
Frequently Asked Questions
What is Edwards Orthopaedics Arthroscopes used for?
They are used for visualizing and treating conditions within joints during minimally invasive surgeries.
What specialties typically use this device?
Orthopedic surgeons primarily use these devices in surgical settings.
What are the FDA-cleared indications?
These devices are indicated for use in minimally invasive procedures to diagnose and treat joint conditions.
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.