# K091310: Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682

- Pathway: 510(k) (Traditional)
- Applicant: Dfine, Inc.
- Decided: Aug 11, 2010 after 464 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: 6 generations back to K943450 (1995). 22 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063172: Arthrocare Cavity Spinewand, Arthrocare Corp. (2007) Summary page 2.
- K992581: Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands, Arthrowands, Arthrocare Corp. (1999) Summary page 2.

## Most influential descendants
- K142480: OsteoCool V-2 RF Ablation System (2015), 9 descendants of its own
- K152057: OsteoCool V-3 RF Ablation System (2015), 8 descendants of its own
- K161949: OsteoCool V-3 RF Ablation System (2017), 7 descendants of its own
- K182497: OsteoCool RF Ablation System (2019), 5 descendants of its own
- K221074: OptaBlate RF Generator, OptaBlate  Probes, OptaBlate Microinfuser Infusion Device (2022), 2 descendants of its own

## Indications for use
The Ablation Instrument is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. The Ablation Generator is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Source page: https://510kreport.com/device/K091310
Methodology: https://510kreport.com/methodology