# K073516: Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular

- Pathway: 510(k) (Traditional)
- Applicant: Kyphon, Inc.
- Decided: Feb 21, 2008 after 69 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: 9 generations back to K896422 (1990). 32 ancestors in all.
No later device cites it as a predicate yet.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063071: Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B, Kyphon, Inc. (2007) Summary page 1.
- 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.

## Indications for use
The Kyphon Discyphor Direct™ 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 Direct™ Outer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Direct™ Inner Needle and Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct™ Outer Needle is intended to be used only with the Discyphor Direct™ Catheter System. The Kyphon Discyphor Direct™ Inner Needle is intended to access the nucleus of an intervertebral disc for the purpose of performing provocative discography and facilitating placement of the Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct™ Inner Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Discyphor Direct™ Inner Needle is intended to be used only with the Discyphor Direct™ Catheter System.

Source page: https://510kreport.com/device/K073516
Methodology: https://510kreport.com/methodology