# K053567: Athrocare Topaz Arthrowands

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Mar 6, 2006 after 74 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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: 7 generations back to K011083 (2001). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011083: Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand, Arthrocare Corp. (2001)
- K052686: Arthrocare Arthrowands, Arthrocare Corp. (2005) Summary page 1.

## Most influential descendants
- K080282: Arthrocare Controllers (System 2000,1100,1200), Model H2076-00, H2079-00, H3000-00, H4000-00; (2008), 1 descendant of its own
- K140521: Topaz EZ Microdebrider Coblation Wand with Integrated Finger Switch (2014), 0 descendants of its own

## Recalls of this device
- Jan 31, 2008 · Not classified · Z-1657-2008: Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure.

## Indications for use
The ArthroCare Topaz ArthroWands are indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: Fasciotomny — Foot Synovectomy — Foot Tendonotomy — Knee, Wrist, Elbow, Ankle, Shoulder, Foot Rotator Cuff Tendonotomy — Shoulder Capsulotomy — Foot

Source page: https://510kreport.com/device/K053567
Methodology: https://510kreport.com/methodology