510(k) · Cleared
ClearedOratec Interventions Ora-50 S Programmable 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 May 17, 1999 as substantially equivalent to K964071 (Oratec Interventions, Inc., 1996) after a 90-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- May 17, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964071 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK964071 Oratec Interventions Model Ora 50 Electrothermal GeneratorOratec Interventions, Inc. · 1996
- This deviceK990474 Oratec Interventions Ora-50 S Programmable Electrothermal Spine…Oratec Interventions, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964071 | Oratec Interventions Model Ora 50 Electrothermal Generator | Oratec Interventions, Inc. | 1996 | — |
| 0 (this device) | K990474 | Oratec Interventions Ora-50 S Programmable Electrothermal Spine System and… | Oratec Interventions, Inc. | 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 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 |
|---|---|---|---|
| * | K964071 | Oratec Interventions Model Ora 50 Electrothermal GeneratorSummary page 1…C ORA-50 S Programmable ElectroThermal Spine System and Accessories are substantially equivalent to the ORATEC ORA-50 ElectroThermal Generator and Accessories (“ORA-507, K964071), currently manufactured and distributed by ORATEC Interventions, Inc. Device Description: The ORATEC Interventions, Inc., ORA-… | 1996 |
| † | K974464 | Oratec Spinecath Intradiscal Catheter | 1998 |
| † | K973158 | Oratec Interventions Model Orastat Monopolar Cautery Device | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K964071.
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 Programmable ElectroThermal Spine System 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 Programmable ElectroThermal Spine System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
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/K990474 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990474: Oratec Interventions Ora-50 S Programmable Electrothermal Spine System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990474
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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