510(k) · Cleared
ClearedOra-50 S Autotemp Electrothermal Spine System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oratec Interventions, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 6, 1999 as substantially equivalent to K974464 (Oratec Interventions, Inc., 1998) after a 21-day review. Its family tree reaches back 2 generations to 1990. 16 later devices descend from it.
- Decided
- Dec 6, 1999
- Review
- 21 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896183 (1990). 6 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK896183 KTP/532 Surgical Laser for Percutaneous DiskectomyLaserscope · 1990
- 1 generation backK974464 Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998
- This deviceK993854 Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc. · 1999
- Descendant · cites it directly · 14 of its ownK033981 Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc. · 2004
- Descendant · 2 generations on · 11 of its ownK130689 Symphony RF GeneratorThermigen, Inc. · 2013
- Descendant · 3 generations on · 6 of its ownK171094 Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017
- Descendant · 4 generations on · 3 of its ownK222260 Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400…Capenergy Medical S.L. · 2023
- Descendant · 2 generations on · 3 of its ownK161661 Thermi RF AccessoriesThermi · 2016
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K033981Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc. · 2004 · cites it directly14descendants
- K130689Symphony RF GeneratorThermigen, Inc. · 2013 · 2 generations on11descendants
- K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017 · 3 generations on6descendants
- K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L. · 2023 · 4 generations on3descendants
- K161661Thermi RF AccessoriesThermi · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896183 | KTP/532 Surgical Laser for Percutaneous Diskectomy | Laserscope | 1990 | — |
| −1 | K974464 | Oratec Spinecath Intradiscal Catheter | Oratec Interventions, Inc. | 1998 | — |
| 0 (this device) | K993854 | Ora-50 S Autotemp Electrothermal Spine System and Accessories | Oratec Interventions, Inc. | 1999 | — |
| +1 | K033981 | Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975 | Smith & Nephew, Inc. | 2004 | — |
| +2 | K130689 | Symphony RF Generator | Thermigen, Inc. | 2013 | — |
| +3 | K171094 | Thermi Reusable Non-invasive RF Electrode | Thermgen, L.L.C | 2017 | — |
| +4 | K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 | Capenergy Medical S.L. | 2023 | — |
| +2 | K161661 | Thermi RF Accessories | Thermi | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K974464 | Oratec Spinecath Intradiscal CatheterSummary page 1…nfiguring the generator for use. A programmed temperature profile mode specifically designed for use with the ORATEC SpineCATH™ device (“SpineCATH Intradiscal Catheter”, K974464) offers the convenience of selecting a treatment profile. Proprietary information: This document and the information contained h… | 1998 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K033981 (Smith & Nephew, Inc., 2004) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K974464.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ORA-50 S AutoTemp ElectroThermal Generator (“ORA-50 S”) and Accessories are intended to be used for general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes. The ORA-50 S ElectroThermal Generator and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Contraindications for Use: The ORA-50 S AutoTemp ElectroThermal Generator and Accessories are contraindicated, when in the judgement of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.
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/K993854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993854: Ora-50 S Autotemp Electrothermal Spine System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993854
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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