# K120527: Alpha Orthopaedics AT2 System

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Orthopaedics, Inc.
- Decided: Jun 18, 2012 after 117 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: 14 generations back to K943450 (1995). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031046: Thermacool TC System, Thermage, Inc. (2003) Summary page 1.
- K082956: Alpha Orthopaedics AT2 System, Alpha Orthopaedics (2008) Summary page 1.

## Indications for use
The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K120527
Methodology: https://510kreport.com/methodology