510(k) · Cleared

Recalled · Class II · 2015

Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece, Altrus Thermal Tissue Fusion System

K140459510(k) TraditionalCleared Jul 11, 2014137-day reviewClass II21 CFR 878.4400Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Conmed Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 11, 2014 as substantially equivalent to K101534 (Conmedcorp, 2010) and 2 other predicates after a 137-day review. Its family tree reaches back 3 generations to 1994. It has been recalled once.

Decided: Jul 11, 2014
Review: 137 days
Class: Class II
Product code: GEI
Recalls: 1
Predicates: 3

Its longest line of descent runs back 3 generations to K932293 (1994). 9 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
2 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
1 generation backK101534 Conmed Altrus Thermal Tissue Fusion SystemConmedcorp · 2010 · Recalled
This deviceK140459 Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue…Conmed Corporation · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K932293	Cabot Medical Bipolar Cutting Forceps	Cabot Medical Corp.	1994	3
−2	K981916	Ligasure Vessel Sealing System	Valleylab, Inc.	1998	—
−1	K101534	Conmed Altrus Thermal Tissue Fusion System	Conmedcorp	2010	8
0 (this device)	K140459	Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion…	Conmed Corporation	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	4	0
1996	1	0
2000	1	0

FIG. 1 — Lineage of K140459, 1994–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K101534	Conmed Altrus Thermal Tissue Fusion System Summary page 1 …Device Name: Altruse Thermal Tissue Fusion System Company Name: Con Med Corporation 510(k): K101534 Device Name: Ultracision Harmonic Scalpel System Company Name: Ethicon Endo-Surger…	Conmedcorp	2010	8
*	K002906	Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07 Summary page 1 …Device Name: Ultracision Harmonic Scalpel System Company Name: Ethicon Endo-Surgery, Inc. 510O(k): K002906 Device Name: Ligasure Vessel Sealing System Company Name: Valleylab, Inc. 5…	Ethicon Endo-Surgery, Inc.	2000	—
*	K981916	Ligasure Vessel Sealing System Summary page 1 …K002906 Device Name: Ligasure Vessel Sealing System Company Name: Valleylab, Inc. 510O(k): K981916 E. Device Description K 140459 Page 2 of…	Valleylab, Inc.	1998	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 5, 2015	Class II	Z-0359-2016	Process control	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 "Check Seal" message with an audible…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
2 of the 9 ancestors have a recall of any class.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140459 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140459: Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece, Altrus Thermal Tissue Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140459

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026