# K140578: Arthroscopic Energy System

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Jul 23, 2014 after 139 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: 7 generations back to K011083 (2001). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082666: Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power Cord, Wands, Arthrocare Corp. (2008) Summary page 1.
- K103665: Conmed R Sabre Genesis TM Electrosurgical Unit; Coned R Sabre Genesis TM Electrosurgical Unit (230V); Conmed Hyfresurg O, Conmed Corporation (2011) Summary page 1.

## Most influential descendants
- K153499: EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension (2015), 0 descendants of its own

## Recalls of this device
- Jun 17, 2015 · Class II · Z-0205-2016: Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.

## Indications for use
The Arthroscopic Energy™ System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.

Source page: https://510kreport.com/device/K140578
Methodology: https://510kreport.com/methodology
