# K101534: Conmed Altrus Thermal Tissue Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Conmedcorp
- Decided: Nov 24, 2010 after 174 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K932293 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K140459: Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece, Altrus Thermal Tissue Fusion System (2014), 0 descendants of its own

## Recalls of this device
- Feb 20, 2014 · Class II · Z-1839-2014: ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.
- Oct 23, 2013 · Class II · Z-0332-2014: The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could presen
- Oct 23, 2013 · Class II · Z-0331-2014: The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could presen
- May 7, 2012 · Not classified · Z-1678-2012: An investigation of the ConMed Electrosurgery Altrus Energy Source revealed that the device could have been calibrated incorrectly resulting in error messages or delays in surgery.
- May 7, 2012 · Not classified · Z-1681-2012: The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
- May 7, 2012 · Not classified · Z-1680-2012: The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
- May 7, 2012 · Not classified · Z-1682-2012: The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
- May 7, 2012 · Not classified · Z-1679-2012: The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.

## 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 (cutting) of tissue when hemostasis is desired.

Source page: https://510kreport.com/device/K101534
Methodology: https://510kreport.com/methodology