# K993854: Ora-50 S Autotemp Electrothermal Spine System and Accessories

- Pathway: 510(k) (Special)
- Applicant: Oratec Interventions, Inc.
- Decided: Dec 6, 1999 after 21 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: 2 generations back to K896183 (1990). 6 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974464: Oratec Spinecath Intradiscal Catheter, Oratec Interventions, Inc. (1998) Summary page 1.

## Most influential descendants
- K033981: Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975 (2004), 14 descendants of its own
- K130689: Symphony RF Generator (2013), 11 descendants of its own
- K171094: Thermi Reusable Non-invasive RF Electrode (2017), 6 descendants of its own
- K222260: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 (2023), 3 descendants of its own
- K161661: Thermi RF Accessories (2016), 3 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K993854
Methodology: https://510kreport.com/methodology