# K140459: Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece, Altrus Thermal Tissue Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Jul 11, 2014 after 137 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: 3 generations back to K932293 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101534: Conmed Altrus Thermal Tissue Fusion System, Conmedcorp (2010) Summary page 1.
- K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07, Ethicon Endo-Surgery, Inc. (2000) Summary page 1.
- K981916: Ligasure Vessel Sealing System, Valleylab, Inc. (1998) Summary page 1.

## Recalls of this device
- Nov 5, 2015 · Class II · Z-0359-2016: Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a

## Indications for use
The ConMed Altrus Thermal Tissue Fusion System is indicated for open and laparoscopic techniques in general surgical and gynecological procedures for ligating (sealing) and dividing (cuffing) of tissue when hemostasis is desired.

Source page: https://510kreport.com/device/K140459
Methodology: https://510kreport.com/methodology