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510(k) Data Aggregation
(14 days)
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) |
|---|---|
| Ablation and Debridement | |
| ACL/PCL | Knee |
| Acromioplasty | Shoulder |
| Articular Cartilage | All Joints |
| Bursectomy | All Joints |
| Chondroplasty | All Joints |
| Facia | All Joints |
| Ligament | All Joints |
| Notchplasty | Knee |
| Scar Tissue | All Joints |
| Soft Tissue | All Joints |
| Subacromial Decompression | Shoulder |
| Synovectomy | All Joints |
| Tendon | All Joints |
| Excision and Resection | |
| Acetabular Labrum | Hip |
| Articular Labrum | All Joints |
| Capsule | All Joints |
| Capsular Release | Knee |
| Cartilage Flaps | Knee |
| Cysts | All Joints |
| Discoid Meniscus | Knee |
| Frozen Shoulder Release | Shoulder |
| Glenoidale Labrum | Shoulder |
| Lateral Release | Knee |
| Ligament | All Joints |
| Loose Bodies | All Joints |
| Meniscal Cystectomy | Knee |
| Meniscectomy | Knee |
| Plica Removal | All Joints |
| Scar Tissue | All Joints |
| Soft Tissue | All Joints |
| Synovial Membrane | All Joints |
| Tendon | All Joints |
| Triangular Fibrocartilage (TFCC) | Wrist |
| Villusectomy | Knee |
| Coagulation | |
| ACL/PCL | Knee |
| Articular Cartilage | All Joints |
| Carpal Ligaments | Wrist |
| Glenohumeral Capsule | Shoulder |
| Ligament | All Joints |
| Medial Retinaculum | Knee |
| Rotator Cuff | Shoulder |
| Tendon | All Joints |
| Wrist Tendons | Wrist |
The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
This 510(k) summary does not contain information on acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document describes modifications to the ArthroCare ArthroWands, which were previously cleared, and asserts that these modifications are not substantial and do not significantly affect safety or efficacy. The review is for "substantial equivalence" to a predicate device, not for specific performance metrics based on new studies.
Therefore, the requested information cannot be extracted from the provided text.
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