# K083306: Modification to Arthrocare Arthrowands

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Dec 10, 2008 after 30 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K011083 (2001). 24 ancestors in all.
14 later devices descend from it; 8 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082980: Arthrocare Arthrowands, Arthrocare Corp. (2008) Summary page 1.

## Most influential descendants
- K143235: RF20000a Controller, FLOW 50 Wand (2015), 4 descendants of its own
- K120791: Ambient Turboflash 90 Ifs (2012), 4 descendants of its own
- K162074: Werewolf RF20000 Controller, FLOW 50 Wand (2016), 3 descendants of its own
- K152777: Bovie Disposable Bipolar Ablator (2016), 3 descendants of its own
- K183346: FLOW 90 Wand (2019), 2 descendants of its own

## Recalls of this device
- Oct 27, 2014 · Class II · Z-0579-2015: Potential breach of sterile barrier due to defective product tray.

## Indications for use
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: 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

Source page: https://510kreport.com/device/K083306
Methodology: https://510kreport.com/methodology