# K073466: Smith & Nephew Intradiscal Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 22, 2008 after 74 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K896183 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013622: Nucleotomy Intradiscal Catheter, Oratec Interventions, Inc. (2002) Summary page 1.
- K993967: Oratec Spinecath Intradiscal Catheter, Model 920002, Oratec Interventions, Inc. (1999) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K073466
Methodology: https://510kreport.com/methodology