# K091228: Spinewand Surgical Device

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Sep 28, 2009 after 154 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001588 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072089: Arthrocare Spinewand, Arthrocare Corp. (2007) Summary page 1.
- K001588: Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Arthrocare System 20, Arthrocare Corp. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K001634: Cardiosentry Event Monitor, Model 8470-01, Tz Medical, Inc. (2000). Our reading of the summary gave K001634, FDA’s number for Cardiosentry Event Monitor, Model 8470-01 (Tz Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ArthroCare System 2000”. Kept off the family tree.

## Indications for use
The Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.

Source page: https://510kreport.com/device/K091228
Methodology: https://510kreport.com/methodology