510(k) · Cleared
Recalled · Class II · 2014Conmed Altrus Thermal Tissue Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmedcorp · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 24, 2010 as substantially equivalent to K981916 (Valleylab, Inc., 1998) and 1 other predicate after a 174-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it. It has been recalled 8 times.
- Decided
- Nov 24, 2010
- Review
- 174 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 2 generations to K932293 (1994). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 1 generation backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- This deviceK101534 Conmed Altrus Thermal Tissue Fusion SystemConmedcorp · 2010
- Descendant · cites it directly · 0 of its ownK140459 Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue…Conmed Corporation · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K140459Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece…Conmed Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −1 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| 0 (this device) | K101534 | Conmed Altrus Thermal Tissue Fusion System | Conmedcorp | 2010 | — |
| +1 | K140459 | Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion… | Conmed Corporation | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K981916 | Ligasure Vessel Sealing SystemSummary page 1…79 GEl Predicate Device: This product is similar in design, composition, and function to the: Valleylab LigaSure Vessel Sealing System (K98 1916) cleared August 28, 1998, as well as the UltraCision Harmonic Scalpel System… | 1998 |
| * | K002906 | Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07Summary page 1…aSure Vessel Sealing System (K98 1916) cleared August 28, 1998, as well as the UltraCision Harmonic Scalpel System (1(002906) cleared December 15, 2000. Device Description: The CONMED Altrus VThermal Tissue Fusion system cons… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140459 | Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece… | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2014 | Class II | Z-1839-2014 | Device Design | 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 | Material/Component Contamination | 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 present to the patient and concluded the… |
| Oct 23, 2013 | Class II | Z-0331-2014 | Material/Component Contamination | 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 present to the patient and concluded the… |
| May 7, 2012 | Not classified | Z-1678-2012 | Equipment maintenance | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K140459 (Conmed Corporation, 2014) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K981916.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 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 (cutting) of tissue when hemostasis is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101534 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101534: Conmed Altrus Thermal Tissue Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101534
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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