# K063071: Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B

- Pathway: 510(k) (Special)
- Applicant: Kyphon, Inc.
- Decided: Apr 13, 2007 after 189 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896422 (1990). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061210: Functional  Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer Needle, Model D01B, Kyphon, Inc. (2006) Summary page 1.
- K043500: Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer Needle, Innospine, Inc. (2005) Summary page 1.

## Most influential descendants
- K073516: Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular (2008), 0 descendants of its own

## Indications for use
The Kyphon Discyphor Catheter System for the Functional Anaesthetic Discography Procedure, and its components, are intended for use in delivering either a single dose or continuous administration of radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space. The Kyphon Discyphor Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Spinal Needle, Discyphor Catheter and Discyphor Guidewire into the intradiscal space. The Kyphon Discyphor Introducer Needle is intended to be used only with the Kyphon Discyphor Catheter System. The Kyphon Discyphor Spinal Needle is intended to access the nucleus of an intervertebral disc for the purpose of performing provocative discography and facilitating placement of the Discyphor Catheter and Guidewire into the intradiscal space. The Discyphor Spinal Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Kyphon Discyphor Spinal Needle is intended to be used only with the Kyphon Discyphor Catheter System.

Source page: https://510kreport.com/device/K063071
Methodology: https://510kreport.com/methodology