510(k) · Cleared
Recalled · Class II · 2016Capsular Shrinkage Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · JOS Electrode, Electrosurgical
Cleared on Aug 20, 1999 as substantially equivalent to K984185 (Oratec Interventions, Inc., 1998) after an 84-day review. Its family tree reaches back 2 generations to 1996. It has been recalled once.
- Decided
- Aug 20, 1999
- Review
- 84 days
- Class
- Class II
- Product code
- JOS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963157 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK963157 Oratec Interventions Model Tac-S Monopolar Cautery Probe (Modify)Oratec Interventions, Inc. · 1996
- 1 generation backK984185 Modification to Tac-S Monopolar Cautery Probe FamilyOratec Interventions, Inc. · 1998
- This deviceK991830 Capsular Shrinkage ElectrodeLinvatec Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963157 | Oratec Interventions Model Tac-S Monopolar Cautery Probe (Modify) | Oratec Interventions, Inc. | 1996 | — |
| −1 | K984185 | Modification to Tac-S Monopolar Cautery Probe Family | Oratec Interventions, Inc. | 1998 | — |
| 0 (this device) | K991830 | Capsular Shrinkage Electrode | Linvatec Corp. | 1999 | — |
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 JOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K984185 | Modification to Tac-S Monopolar Cautery Probe FamilySummary page 3…lization Interventions, Inc. | Cautery Probe [ wrist, elbow and knee Hub/Connector: ABS Plastic Method Unknown | Working Length: 6 in. 510(k)}# arthroscopic procedures K984185 Monopolar PREDICATE ARTHROWAND | Electro-coagulation of soft | Shaft: 300 Series Stainless Steel Single-Use Degree/Diameter: Arth… | 1998 |
| * | — | ArthoWand CAPS Named without a submission number |
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 |
|---|---|---|---|---|
| Aug 29, 2016 | Class II | Z-0085-2017 | Process change control | CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it could increase the risk of patient burn. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K984185.
How does its category compare?
All JOS devicesJOS Electrode, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JOS
Too few JOS 510(k)s in any year since 2007 to give a median.
Recalls per year · JOS
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOS
6in 2025
MAUDE reports naming product code JOS, 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 | 0 | — | 0 | 29 |
| 2008 | 0 | — | 1 | 37 |
| 2009 | 0 | — | 0 | 62 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 2 | 7 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 2 | 17 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991830: Capsular Shrinkage Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991830
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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