510(k) · Cleared
ClearedSmith & Nephew Intradiscal Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 22, 2008 as substantially equivalent to K013622 (Oratec Interventions, Inc., 2002) and 1 other predicate after a 74-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Feb 22, 2008
- Review
- 74 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K896183 (1990). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK896183 KTP/532 Surgical Laser for Percutaneous DiskectomyLaserscope · 1990
- 3 generations backK974464 Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998
- 2 generations backK993967 Oratec Spinecath Intradiscal Catheter, Model 920002Oratec Interventions, Inc. · 1999
- 1 generation backK013622 Nucleotomy Intradiscal CatheterOratec Interventions, Inc. · 2002
- This deviceK073466 Smith & Nephew Intradiscal Catheter SystemSmith & Nephew, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896183 | KTP/532 Surgical Laser for Percutaneous Diskectomy | Laserscope | 1990 | — |
| −3 | K974464 | Oratec Spinecath Intradiscal Catheter | Oratec Interventions, Inc. | 1998 | — |
| −2 | K993967 | Oratec Spinecath Intradiscal Catheter, Model 920002 | Oratec Interventions, Inc. | 1999 | — |
| −1 | K013622 | Nucleotomy Intradiscal Catheter | Oratec Interventions, Inc. | 2002 | — |
| 0 (this device) | K073466 | Smith & Nephew Intradiscal Catheter System | Smith & Nephew, Inc. | 2008 | — |
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 |
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 |
|---|---|---|---|
| * | K013622 | Nucleotomy Intradiscal CatheterSummary page 1…ic patients with contained herniated discs. Technological Characteristics: The proposed Intradiscal Catheter System is ieic nrdicate Nucleotomv Catheter (K013622) and Spinecath Intradiscal Catheter (K993967) 9 PWWeFN Substantial Equivalence information: Performance testing of… | 2002 |
| * | K993967 | Oratec Spinecath Intradiscal Catheter, Model 920002Summary page 1…Technological Characteristics: The proposed Intradiscal Catheter System is ieic nrdicate Nucleotomv Catheter (K013622) and Spinecath Intradiscal Catheter (K993967) 9 PWWeFN Substantial Equivalence information: Performance testing of the proposed Intradiscal Catheter System demo… | 1999 |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Spinecath Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
The Acutherm Decompression Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073466 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073466: Smith & Nephew Intradiscal Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073466
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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