# K093086: Arthrosteer Ablator & Coagulator, Models: Ref 1070 & 1080

- Pathway: 510(k) (Traditional)
- Applicant: Orthodynamix, LLC
- Decided: Feb 23, 2010 after 145 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ArthroSteer Ablator and Coagulator are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissue in joints including, but not limited to, the knee, shoulder, wrist and hip.

Source page: https://510kreport.com/device/K093086
Methodology: https://510kreport.com/methodology